Z-0209-2007

Zimmer NexGen Complete Knee Solution Legacy Knee Tibial Component, 3 degree, fluted, size 4, stemmed option...

Name: Z-0209-2007 Zimmer NexGen Complete Knee Solution Legacy Knee Tibial Component, 3 degree, fluted, size 4, stemmed option...
Creator: Zimmer Inc.
Published: 2006-10-12
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2006-10-12 / Terminated

FDA source

Zimmer Inc. began a recall of Zimmer NexGen Complete Knee Solution Legacy Knee Tibial Component, 3 degree, fluted, size 4, stemmed option, for cemented use only, tivanium TI-6AL-4V... on 2006-10-12. The reason FDA records is "The polyethylene tibial articular surface may not lock into some of the tibial plates". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0209-2007
Status: Terminated
Initiated: 2006-10-12
Posted: 2006-11-22
Terminated: 2007-12-10
Recalling firm: Zimmer GmbH
Product: Zimmer NexGen Complete Knee Solution Legacy Knee Tibial Component, 3 degree, fluted, size 4, stemmed option, for cemented use only, tivanium TI-6AL-4V alloy/UHMWPE, sterile; Catalog no. 05-5998-038-02.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The polyethylene tibial articular surface may not lock into some of the tibial plates.
FDA root cause: Other
Action: Consignees were notified by a letter dated 10/12/06 and sent to operating room supervisors and Zimmer distributors to cease using the product and to return it to the firm.
Quantity in commerce: 18
Distribution: Nationwide.
Product codes and lots: Lot 60472442; exp. May 2011.

Product code JWH

K963148Class IINexgen Complete Knee SolutionZimmer, Inc. / cleared 1997-02-13

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)