[Company Name]

[Company Group, Division, Location]

Document Title: Correction or Removal of Marketed Product

Document Number: [Document Number]
Document Filename: [Document Filename]

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COMPANY PROPRIETARY AND CONFIDENTIAL

[Company Name] Correction or Removal of Marketed Product
[Company Group, Division, Location] [Document Number]
Rev x.xx DD/MM/YY

Table of Contents

1.0 Purpose..........................................................................................................................................................3

2.0 Scope.............................................................................................................................................................3

3.0 Definition Of Terms......................................................................................................................................3

3.1 Recall..................................................................................................................................................3
3.1.1 Mandatory Recall.................................................................................................................3
3.1.2 Voluntary Recall...................................................................................................................3
3.2 Removal..............................................................................................................................................3
3.3 Correction...........................................................................................................................................3
3.4 FDA....................................................................................................................................................3
3.5 Device User Facility...........................................................................................................................3
3.6 Health Professionals...........................................................................................................................3
3.7 Market Withdrawal............................................................................................................................3
3.8 Marketed Product...............................................................................................................................3
3.9 Reasonable Probability.......................................................................................................................4
3.10 Serious Adverse Health Consequence................................................................................................4
3.11 Stock Recovery...................................................................................................................................4
3.12 Recall Strategy...................................................................................................................................4
3.13 Cease Distribution And Notification Strategy or Mandatory Recall Strategy..................................4
3.14 Recall Classification..........................................................................................................................4
3.14.1 Class I..................................................................................................................................4
3.14.2 Class 11................................................................................................................................4
3.14.3 Class III................................................................................................................................4
3.15 Consignee...........................................................................................................................................4

4.0 References.....................................................................................................................................................4

5.0 Responsibilities and Requirements...............................................................................................................5

5.1 [Officers Title}, Quality Systems.......................................................................................................5
5.2 [COMPANY NAME] Top Management............................................................................................5

6.0 Voluntary Correction or Removal.................................................................................................................5

6.1 Problem Evaluation............................................................................................................................5
6.1.1 Health Hazard Evaluation...................................................................................................5
6.1.2 Regulatory Evaluation.........................................................................................................6
6.1.3 Determining Number of Problem Units and Distribution Status.......................................6
6.2 Appropriate Actions...........................................................................................................................6
6.2.1 No Action Required.............................................................................................................6
6.2.2 Stock Recovery.....................................................................................................................6
6.2.3 Market Withdrawal..............................................................................................................6
6.2.4 Correction or Removal........................................................................................................7
6.3 Correction or Removal Strategy........................................................................................................7
6.3.1 Extent of Correction or Removal........................................................................................7
6.3.2 Notice to Individuals Subject to Risk..................................................................................7
6.3.3 Effectiveness Checks...........................................................................................................7
6.3.4 Logistics...............................................................................................................................7

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Table of Contents (cont.)

6.4 Execution of Correction or Removal.................................................................................................7

6.4.1 Communications..................................................................................................................7
6.5 Effectiveness Checks..........................................................................................................................8
6.6 Status Reports.....................................................................................................................................8
6.7 Termination........................................................................................................................................8

7.0 Mandatory Actions........................................................................................................................................8

8.0 Medical Devices Vigilance System...............................................................................................................9

9.0 Flow Chart..................................................................................................................................................10

9.1 Voluntary Correction or Removal....................................................................................................10
9.2 FDA Mandatory Recall....................................................................................................................11
9.3 Medical Devices Vigilance System..................................................................................................12

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1.0 Purpose
To create a method for the correction or removal of a marketed product.

2.0 Scope
This procedure pertains to the correction or removal of all marketed products manufactured at the
facilities of [COMPANY NAME].

3.0 Definition Of Terms

3.1 Recall
The correction or removal by [COMPANY NAME] of a marketed product which has a reasonable
probability of causing serious adverse health consequences or death, or a product which is in
violation of the laws administered by the Food and Drug Administration and would be subject to
legal action, such as seizure, by the FDA. Recall does not include a market withdrawal or a stock
recovery.

3.1.1 Mandatory Recall

A recall ordered by a regulatory agency, typically the FDA.

3.1.2 Voluntary Recall

A recall initiated by [COMPANY NAME], without a regulatory agency order mandating
recall.

3.2 Removal
The physical removal of a product from its point of use to some other location for repair,
modification, adjustment, relabeling, destruction, or inspection.

3.3 Correction
Repair, modification, adjustment, relabeling, destruction, or inspection (including patient
monitoring) of a product without its physical removal from its point of use to some other
location.

3.4 FDA
US Federal Food and Drug Administration.

3.5 Device User Facility

A hospital, ambulatory surgical facility, nursing home, or outpatient treatment or diagnostic 
facility that is not a physician's office.

3.6 Health Professionals

Practitioners, including physicians, nurses, pharmacists, dentists, respiratory therapists, physical
therapists, technologists, or any other practitioners or allied health professionals that have a role
in using a device for human use.

3.7 Market Withdrawal

A firm's correction or removal of a distributed product which involves a minor violation that
would not be subject to legal action by the Food and Drug Administration or which involves no
violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.

3.8 Marketed Product

Any product released into the distribution system for sale or use, which has left the direct control
of [COMPANY NAME].

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3.9 Reasonable Probability

It is more likely than not that an event will occur.

3.10 Serious Adverse Health Consequence

Any significant adverse experience, including those that may be either life-threatening of involve
permanent or long-term injuries, but excluding injuries that are not life-threatening and that are
temporary and reasonably reversible.

3.11 Stock Recovery

A firm's correction or removal of a product that has not been marketed or that has not left the
direct control of the firm, i.e., the product is located on premises owned by, or under the control
of, the firm and no portion of the lot has been released for sale or use.

3.12 Recall Strategy

A planned specific course of action to be taken in conducting a specific recall, which addresses
the depth of recall, need for public warnings, and extent of effectiveness checks for the recall.

3.13 Cease Distribution And Notification Strategy or Mandatory Recall Strategy

A planned, specific course of action to be taken by the person named in a cease distribution and
notification order or in a mandatory recall order, which addresses the extent of the notification or
recall, the need for public warnings, and the extent of effectiveness checks to be conducted.

3.14 Recall Classification

The numerical designation, i.e., I, II, or III, assigned by the Food and Drug Administration to a
particular product recall to indicate the relative degree of health hazard presented by the product
being recalled.

3.14.1 Class I
A situation in which there is a reasonable probability that the use of, or exposure to, the
product will cause serious adverse health consequences or death.

3.14.2 Class 11
A situation in which use of, or exposure to, the product may cause temporary or
medically reversible adverse health consequences or where the probability of serious
adverse health consequences is remote.

3.14.3 Class III

A situation in which use of, or exposure to, the product is not likely to cause adverse
health consequences.

3.15 Consignee
Any person or firm that has received, purchased, or used the product. Consignee does not mean
lay individuals or patients, i.e., nonhealth professionals.

4.0 References
 Marketed Product Correction/Removal Form
 Vigilance System Final Report
 Vigilance System Initial Incident Report
 Enforcement Policy
 Medical Device Corrections And Removals
 Medical Device Recall Authority
 Methods for Conducting Recall Effectiveness Checks, FDA Guidance
 Active Implantable Medical Devices Directive
 Medical Devices Directive
 The Medical Devices Vigilance System, a European Commission Guidelines

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5.0 Responsibilities and Requirements

5.1 [Officers Title}, Quality Systems

The [Officers Title], Quality Systems is responsible for determining appropriate action(s) to be
taken when an issue with a marketed product is discovered.

5.2 [COMPANY NAME] Top Management

It is the duty of Top management to assist with the clinical and technical evaluation of, and
helping to find root cause and recommend solutions for, any problem with a marketed product
which may require correction or removal. Top management also holds the duty of assisting with
location of the product in the distribution chain, and assisting with the logistics and performance
of the correction or removal.

6.0 Voluntary Correction or Removal

Situations may arise where [COMPANY NAME] may realize there is a problem with a marketed
product, which may necessitate a correction or removal of that product. The problem may be with the
product, packaging, or product labeling. [COMPANY NAME] may learn of the problem through
complaints, returned product, or through [COMPANY NAME] 's internal testing or corrective and
preventive action.
For product regulated by the FDA, the requirements for a voluntary correction or removal are codified
in 21 CFR Part 7, Enforcement Policy.

For medical devices marketed in the European Community under the “CE” mark, in addition to the
requirements of this section (Section 6), a voluntary correction or removal must also comply with the
Medical Devices Vigilance system (Section 8).

This section (Section 6) is based on the requirements in 21 CFR Part 7, but is applicable to the
voluntary correction or removal of any marketed [COMPANY NAME] product, even if the FDA does
not regulate the product.

A correction or removal of [COMPANY NAME] marketed product begun and finalized by [COMPANY
NAME] is considered voluntary unless an order is received from a regulatory agency mandating the
action. A correction or removal recommended or suggested by a regulatory agency, but initiated by
[COMPANY NAME], is still considered voluntary. If at any time prior to or during a chosen correction
or removal, an order is received from a regulatory agency mandating the action, the action becomes
compulsory. See Section 7. Mandatory Actions.

6.1 Problem Evaluation

[COMPANY NAME] will consider the following issues when determining the seriousness of the
problem and the appropriate measures to be taken.

 Does the product present a health hazard, and if so, to what degree?
 Is the product in violation of regulatory agency requirements, and if so, are violations
considered major or minor?
 How many units of product have the problem, and where are those units in the distribution
chain?

6.1.1 Health Hazard Evaluation

Based on the following factors, and other relevant data, [COMPANY NAME] will
evaluate the degree of health hazard, if any, presented by the artifact. For medical
devices, [COMPANY NAME] will estimate if the degree of health hazard falls within
the FDA definition of a Class I, II, or III Recall.
 Have injuries or disease already occurred from product use?
 Could other conditions contribute to health hazard situations?
 Are certain segments of the population at higher risk?
 Seriousness of health hazard?

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 Likelihood of hazard occurrence?

 Immediate and long-range consequences of health hazard?

6.1.2 Regulatory Evaluation

Issues with the product must be evaluated for potential violation of regulatory agency
requirements, and whether any such violations are considered major or minor by the
regulatory agency. For instance, product regulated by the FDA may be in violation of the
Federal Food, Drug, and Cosmetic Act, as amended and codified in Title 21 of the Code
of Federal Regulations.

6.1.3 Determining Number of Problem Units and Distribution Status

To identify the number of problem units, the cause or root of the problem must first be
identified. Once the problem cause or root is known, the specific product lots or serial
numbers exposed to the cause or root can be listed and tallied. Distribution records for
these lots or serial numbers will then indicate where these units are in the distribution
chain.

6.2 Appropriate Actions

Based on the results of the problem evaluation, and with input from clinical and technical 
functions and top management, the [Officers Title], Quality Systems will select the appropriate 
action(s) to be initiated.

6.2.1 No Action Required

 If inquiry shows that an issue did not occur or the problem report was in error,
then no action to correct or remove marketed product is required.
 If evaluation of a problem reveals no health risk and no violation of regulatory
requirements, and there is no business reason for conducting a correction or
removal of marketed product, then no action is required.
If no action is required, this procedure ends.

6.2.2 Stock Recovery

If circulation records show that the problem product is still under the direct control of 
[COMPANY NAME] and that no units have been sold or used, then a correction or 
removal is actually a stock recovery and not a recall.  Proceed with development of a 
correction or removal strategy for stock recovery.  Regulatory agency notification is not 
required, but accurate documentation of the stock recovery should be retained for a 
minimum period of two years beyond the expected life of the product.

6.2.3 Market Withdrawal

If assessment of a problem indicates the need for a correction or removal of a distributed 
product that involves a minimal regulatory violation that would not be subject to legal 
action by the regulatory agency (i.e. FDA), then the correction or removal is termed a 
market withdrawal, and not a recall.  Continue with development of a correction or 
removal strategy for market withdrawal.  Notification of the regulatory agency is not 
mandated, but voluntary regulatory agency notification may be wise to assure agreement
with the judgment that the action is a market withdrawal, and not a recall.  Accurate 
documentation of the market withdrawal should be retained for a minimum period of 
two years beyond the expected life of the product.  Normal stock rotation and routine 
equipment tune­ups and repairs are not deemed recalls and are not subject to this 
procedure.

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6.2.4 Correction or Removal

If evaluation of a problem indicates the need for a correction or removal of a marketed
product, then a correction or removal strategy will be developed. If the marketed
product is a medical device and the correction or removal meets the definition of a Class
I or II Recall, the FDA must be notified, unless the FDA has already been notified under
Medical Device Reporting requirements.

6.3 Correction or Removal Strategy

[COMPANY NAME] will develop an appropriate correction or removal strategy, based on: health
hazard evaluation; ease of product identification; extent to which the risk presented by the
product is obvious to the user, extent to which the product is used. The strategy will address the
following elements:

6.3.1 Extent of Correction or Removal

The level in the distribution chain to which the correction or removal will extend.

 Consumer or user level (health professional, consignee, or product user

facility), including any intermediate wholesale or retail level.
 Retail level, to the level immediately preceding the consumer or user level, and
including any intermediate wholesale or retail level.
 Wholesale level.

6.3.2 Notice to Individuals Subject to Risk

If the product subjects individuals to risk, then the correction or removal strategy must
provide for notification of those individuals. Notification will usually be through an
individual's health professional. In rare instances of extreme risk, and/or when
individuals subject to the risk cannot be identified, a public warning of the risk may be
necessary.

6.3.3 Effectiveness Checks

Effectiveness checks verify that notification of the correction or removal is reaching the
proper persons or facilities, and suitable action is being taken. The strategy will specify
the method and level of effectiveness checks, with levels defined as:

 Level A, 100% of consignees contacted

 Level B, >10% and <100% of consignees contacted (percentage specified)
 Level C, 10% of consignees contacted
 Level D, 2% of consignees contacted
 Level E, no effectiveness checks

6.3.4 Logistics
The strategy will also speak to such questions as: who, when, where, and how will the
correction or removal be performed; is correction, removal, or a combination of
correction and removal appropriate; availability of replacement units; etc.

6.4 Execution of Correction or Removal

6.4.1 Communications
[COMPANY NAME] will notify all consignees via verified written communication of 
the correction or removal action.  The written communication will be clearly marked 
with the action type (correction, removal, recall, advisory, etc.), and will:

 Be brief and to the point (no irrelevant information that may detract from the
message)
 Clearly identify the product, including lot and serial numbers, and description

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 State the action, explain the reason for the action, and any health hazard
 Provide specific instructions for product disposition
 Provide a ready means of verifying to [COMPANY NAME] that the
communication was received (self addressed postcard, collect call, etc.)
 If appropriate, provide instructions regarding extent of action (i.e. does strategy
require consignee to notify customers of action?)

6.5 Effectiveness Checks

Effectiveness checks will be conducted to the level defined in the correction or removal strategy
by written communications, personal visits, and/or telephone calls, to assure that health
professionals, device user facilities, consignees, and persons, as appropriate, have received notice
of the correction or removal and have taken appropriate action. Methods for Conducting Recall
Effectiveness Checks, an FDA guidance, may be referenced.

6.6 Status Reports

Status reports to assess progress will be prepared at periodic intervals stated in the correction or
removal strategy, and submitted to the regulatory agency, if necessary. The status report will
contain:

 # of consignees notified, date and method of notification

 # of consignees responding to notification, amount of product on hand
 # of consignees not responding
 # of products corrected or removed by each consignee, and quantity of products accounted for
 # and results of effectiveness checks
 Estimated time frame for completion

The preparation and submission, if required, of status reports will cease when the correction or
notification is terminated.

6.7 Termination
 When objectives of the correction or removal strategy have been met, and required actions
are complete, the correction or removal action should be terminated.
 If regulatory agency concurrence is required for termination, a letter stating that the action
was effective, and including the last status report and the disposition of product, should be
sent to the appropriate regulatory agency office requesting termination.
 If the regulatory agency concurs in writing, the action is
terminated.
 If the regulatory agency does not concur, continue the
correction or removal action and address specific agency
concerns.
 If concurrence from a regulatory agency is not required for termination, record the decision
to terminate in a letter to file, and terminate the action.

7.0 Mandatory Actions

A directive from a regulatory agency requiring [COMPANY NAME] to initiate action regarding a
marketed [COMPANY NAME] product is considered a mandatory action, even if the action began as a
voluntary correction or removal before the order was received. While the elements of a voluntary
correction or removal should be considered during a mandatory action, [COMPANY NAME] must
comply with the requirements of the regulatory agency order, and the regulatory agency order will take
precedence over the voluntary correction or removal requirements, if there is any conflict.
For compulsory actions related to medical devices, the FDA's requirements are codified in 21 CFR Part
810, Medical Device Recall Authority. The FDA Mandatory Recall flow chart illustrates the steps and
requirements for an FDA mandatory recall, although 21 CFR Part 810 should be referenced for detailed
requirements.

Products marketed outside of the USA also may be subject to mandatory actions by the countries in
which the products are sold. For medical devices marketed in the European Community under the “CE”

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mark, in addition to the requirements of this section (Section 7, Mandatory Actions), must comply with
the Medical Devices Vigilance system (Section 8, Medical Devices Vigilance System).

For any mandatory action, [COMPANY NAME] will without delay comply with the action, appeal the
action if appropriate, complete requirements of the action, and have the action terminated.

8.0 Medical Devices Vigilance System

The correction or removal of a [COMPANY NAME] medical device marketed in the European
Community under the “CE” mark is subject to the Medical Devices Vigilance system, in addition to
Sections 6, Voluntary Correction or Removal or 7, Mandatory Actions of this procedure.

The requirements of the Medical Devices Vigilance system are stated in Article 8 of the Active
Implantable Medical Devices Directive (90/385/EEC), and in Article 10 of the Medical Devices
Directive (93/42/EEC). Additional guidance is available in The Medical Devices Vigilance System, a
European Commission Guidelines.

To comply with the requirements of the Medical Devices Vigilance system consult the Directives and
Guidance for details. Use the Vigilance System Initial Incident Report form and the Vigilance System
Final Report form for filing the initial and final reports, respectively, with the appropriate Competent
Authority.

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9.0 Flow Chart

9.1 Voluntary Correction or Removal

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9.2 FDA Mandatory Recall

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9.3 Medical Devices Vigilance System

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