Recalls / —

—#155476

Product

Reusable instruments in the Knee, Hip, Trauma, and Extremities segments.

FDA product code

N/A

Affected lot / code info

All lots in distribution prior to 5/8/17

Why it was recalled

Durability characteristics of reusable instruments were not established

Root cause (FDA determination)

Device Design

Action the firm took

On 5/8/2017, URGENT MEDICAL DEVICE RECALL (CORRECTION) notifications were sent to the affected US sales representatives and distributors via e-mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Your Responsibilities: 1. Review this notification and ensure affected team members are aware of the contents. 2. Distributors return the Attachment 1 Acknowledgment Form to corporatequality.postmarket@zimmerbiomet.com (Return one form per territory. Sales representatives do not need to sign an acknowledgment form.) 3. Training will automatically be assigned to sales representatives and distributors, and a list of these trainees will be provided. Review the list of trainees to ensure that all applicable sales representatives are listed. If you have additional trainees to report, send a list that includes the trainees name, title, and email address to corporatequality.postmarket@zimmerbiomet.com. 4. Access the computer-based training. a. Log into Biomet University and navigate to your learning requirements. b. Complete the computer-based training module for the Reusable Instrument Lifespan Manual listed in your learning requirements. c. Complete the accompanying course assessment. 5. Access the RILM one of two ways: a. Via direct link http://www.zimmer.com/medical-professionals/support/disassembly-manual-reusable-instrument-lifespan-manual.html b. Via path Zimmer.comMedical ProfessionalsSupport Drop-DownDisassembly Manual/Reusable Instrument Lifespan Manual. 6. Immediately begin using the RILM to evaluate reusable instruments according to the training guidance. 7. If you have questions about the RILM, please contact Michael Aziz: Michael.Aziz@zimmerbiomet.com. International distributors will be notified via email. Further distribution of international notices will be sent through the local and

Recalling firm

Firm

Zimmer Biomet, Inc.

Address

1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern

Nationwide Worldwide

Timeline

Recall initiated

2017-05-08

Posted by FDA

2017-05-22

Terminated

2017-12-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #155476. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.