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

FDA device recall Z-2198-2017 · posted 2017-05-22 · Terminated

Recall details

Recalling firm

Zimmer Biomet, Inc.

Reason for recall

Durability characteristics of reusable instruments were not established

Action taken

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

Root cause

Device Design

Status

Terminated

Product code

N/A

Quantity affected

Greater than 10,000,000 last 10 years

Distribution

Nationwide Worldwide

Date initiated

2017-05-08

Date posted

2017-05-22

Date terminated

2017-12-01

Location

Warsaw, IN