Z-2198-2017Class II

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

Name: Z-2198-2017 Reusable instruments in the Knee, Hip, Trauma, and Extremities segments
Creator: Zimmer Biomet, Inc.
Published: 2017-05-08
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-05-08 / Terminated / root cause: design

FDA source

Zimmer Biomet, Inc. began a recall of Reusable instruments in the Knee, Hip, Trauma, and Extremities segments on 2017-05-08. FDA classified it as Class II and gives the reason as "Durability characteristics of reusable instruments were not established". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2198-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-08
Posted: 2017-05-22
Terminated: 2017-12-01
Recalling firm: Zimmer GmbH
Product: Reusable instruments in the Knee, Hip, Trauma, and Extremities segments.
Product code: N/A
Reason for recall: Durability characteristics of reusable instruments were not established
Root cause tag: design
FDA root cause: Device Design
Action: 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 [email protected] (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 [email protected]. 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: [email protected]. International distributors will be notified via email. Further distribution of international notices will be sent through the local and
Quantity in commerce: Greater than 10,000,000 last 10 years
Distribution: Nationwide Worldwide
Product codes and lots: All lots in distribution prior to 5/8/17

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2198-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2198-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-05-31

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)