FEM COND BUTTRESS PLT, LT

FDA device recall Z-0591-2014 · posted 2013-12-27 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure

Action taken

On 11/5/2013, Urgent Medical Device Recall Notifications were sent to affected distributors, hospital Risk Managers, and doctors informing them of the failure. All distributors were notified via electronic mail. Hospital risk managers, surgeons and distributors with affected inventory within the expiration date of the device will also be notified via courier. The letter identifies the issue, health risks, and their responsibilities. Questions concerning the recall are directed to 1-877-946-2761 Communications outside of the United States will occur approximately two weeks after the United States communications. Zimmer will conduct effectiveness checks in the following way: Distributors/Hospitals/Surgeons 100% of the notifications will be tracked to ensure delivery of the notifications. An inventory certification form will need to be returned from each distributor that certifies that all available affected product from their territory has been returned. Additional notifications via email and FedEx will be sent to those who have not completed the required certification form or returned affected product. Accounts will be deemed unresponsive after 3 attempts.

Root cause

Process change control

Status

Terminated

Product code

HRS

Quantity affected

42, 065 units total

Distribution

Worldwide Distribution.

Date initiated

2013-11-05

Date posted

2013-12-27

Date terminated

2015-05-05

Location

Warsaw, IN

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