—#122910

Product

DIST LAT FEM LOCK PLT, LT

FDA product code: FZS — Curette, Surgical, General Use
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K082078
Affected lot / code info: Item Number: 47-2357-102-14 47-2357-102-18 All lots with an expiration date prior to July 24, 2023

Why it was recalled

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

Root cause (FDA determination)

Process change control

Action the firm took

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.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Worldwide Distribution.

Timeline

Recall initiated: 2013-11-05
Posted by FDA: 2013-12-27
Terminated: 2015-05-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122910. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.