Z-0501-2010

Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee- Posterior Stabilized, Gender Solutions...

Name: Z-0501-2010 Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee- Posterior Stabilized, Gender Solutions...
Creator: Zimmer Inc.
Published: 2009-11-13
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-11-13 / Terminated / root cause: packaging

FDA source

Zimmer Inc. began a recall of Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee- Posterior Stabilized, Gender Solutions Female, Femoral Component, option, LPS-flex, size C... on 2009-11-13. The reason FDA records is "The inner package may interfere with the outer seal, resulting in lack of assurance of sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0501-2010
Status: Terminated
Initiated: 2009-11-13
Posted: 2009-12-14
Terminated: 2010-10-15
Recalling firm: Zimmer GmbH
Product: Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee- Posterior Stabilized, Gender Solutions Female, Femoral Component, option, LPS-flex, size C, right, for cemented use only; REF 00-5764-013-52.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The inner package may interfere with the outer seal, resulting in lack of assurance of sterility.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Zimmer sent a recall letter, dated 11/12/09, to each initial consignee on 11/13/09. Zimmer field staff is to remove the product from affected hospitals, and to provide them with a copy of the recall letter.
Quantity in commerce: 22
Distribution: Nationwide, Korea and Switzerland.
Product codes and lots: Lot 61042477.

Product code JWH

K060370Class IINexgen Knee Gender Solutions Female (Gsf) Femoral ComponentsZimmer, Inc. / cleared 2006-04-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)