Z-0915-2010

NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc...

Name: Z-0915-2010 NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc...
Creator: Zimmer Inc.
Published: 2010-01-27
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2010-01-27 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Inc. began a recall of NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc. Warsaw, IN on 2010-01-27. The reason FDA records is "The package should contain the left knee component but actually contains the right knee component. Delay in completing surgery may result, and a new or different implant may need to be identified". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0915-2010
Status: Terminated
Initiated: 2010-01-27
Posted: 2010-03-02
Terminated: 2010-10-17
Recalling firm: Zimmer GmbH
Product: NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc. Warsaw, IN.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The package should contain the left knee component but actually contains the right knee component. Delay in completing surgery may result, and a new or different implant may need to be identified.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm sent an immediate notification by e-mail to all first consignees on 1/12/2010. They sent a formal recall notification on 1/27/2010. Customers should contact their Zimmer Sales representative with additional questions.
Quantity in commerce: 14 units
Distribution: US and Korea.
Product codes and lots: lot 61369812.

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)