Z-0205-2010

Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 11 MM...

Name: Z-0205-2010 Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 11 MM...
Creator: Zimmer Inc.
Published: 2009-10-08
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-10-08 / Terminated

FDA source

Zimmer Inc. began a recall of Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 11 MM height, use with baseplate size 1 or 2, sterile... on 2009-10-08. The reason FDA records is "The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0205-2010
Status: Terminated
Initiated: 2009-10-08
Posted: 2009-11-13
Terminated: 2011-05-16
Recalling firm: Zimmer GmbH
Product: Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 11 MM height, use with baseplate size 1 or 2, sterile, Zimmer, Warsaw, IN; REF 00-5424-011-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
FDA root cause: Other
Action: An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool. Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if you have any questions regarding this action. For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
Quantity in commerce: 26,404 of all products
Distribution: Worldwide Distribution -- United States, Austria, Belgium, France, Germany, Japan, Spain and Switzerland.
Product codes and lots: Lots 60916390, 60916392, 60916393, 60916424, 60930896, 60947731, 60954140, 60954150, 60958269, 60964459, 60964479, 60981787, 60981801, 60987819, 60987833, 60987834, 60992923, 60992924, 61001544, 61005434, 61005448, 61023610, 61027878, 61036338, 61036367, 61036368, 61051468, 61064799, 61069407, 61075236, 61078744, 61078745, 61091176, 61091192, 61091193, 61101449, 61101450, 61106550, 61114163, 61114174, 61117033, 61117050 and 61122282.

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)