Z-1477-2009

Zimmer Gender Solutions Natural Knee Flex System, Gender Solutions Male, Femoral Component, nonporous, size...

Name: Z-1477-2009 Zimmer Gender Solutions Natural Knee Flex System, Gender Solutions Male, Femoral Component, nonporous, size...
Creator: Zimmer Inc.
Published: 2009-04-29
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-04-29 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of Zimmer Gender Solutions Natural Knee Flex System, Gender Solutions Male, Femoral Component, nonporous, size 4, left, sterile, Zimmer, Warsaw, IN; Product... on 2009-04-29. The reason FDA records is "The tyvek lid, which is intended to assure sterility until the device is transported to the operating room, may be missing from the inner tray". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1477-2009
Status: Terminated
Initiated: 2009-04-29
Posted: 2009-06-26
Terminated: 2009-10-21
Recalling firm: Zimmer GmbH
Product: Zimmer Gender Solutions Natural Knee Flex System, Gender Solutions Male, Femoral Component, nonporous, size 4, left, sterile, Zimmer, Warsaw, IN; Product Number: 00-5410-017-01. Knee implant used to replace the distal surface of the human femur in total knee arthroplasty surgery. For use in Non-inflammatory Degenerative Joint Disease or Inflammatory Joint Disease, deformity, moderate contracture or failed previous surgery. Product is indicated for uncemented or cemented use.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The tyvek lid, which is intended to assure sterility until the device is transported to the operating room, may be missing from the inner tray.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Zimmer, Inc. issued an "Urgent: Device Recall" letter dated April 29, 2009 informing all consignees of the affected product. Users were instructed to locate and quarantine all unused devices and ship them to the firm with a completed Inventory Return Certification form. Return Certification forms are also to be sent via fax to Zimmer, Inc. at 1-574-372-4265. For further questions, contact Zimmer, Inc. at 1-800-613-6131.
Quantity in commerce: 14
Distribution: Worldwide Distribution -- US including states of FL, MN, MS, NY, OH, TN, TX and WI and Switzerland.
Product codes and lots: Lot Number: 60998487.

Product code JWH

K070214Class IIGender Solutions Natural-Knee Flex SystemZimmer, Inc. / cleared 2007-03-16

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)