Z-1064-2010

Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Technology...

Name: Z-1064-2010 Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Technology...
Creator: Zimmer Inc.
Published: 2009-11-16
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-11-16 / Terminated

FDA source

Zimmer Inc. began a recall of Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Technology Tibial Tray, fixed bearing, size 8, sterile, Zimmer... on 2009-11-16. The reason FDA records is "The titanium portion of the implant may separate from the trabecular metal material". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1064-2010
Status: Terminated
Initiated: 2009-11-16
Posted: 2010-03-10
Terminated: 2011-03-23
Recalling firm: Zimmer GmbH
Product: Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Technology Tibial Tray, fixed bearing, size 8, sterile, Zimmer, Warsaw, Indiana; REF 00-5954-057-02. The product is used as an implant for knee replacement.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The titanium portion of the implant may separate from the trabecular metal material.
FDA root cause: Other
Action: On December 1, 2009, an e-mail was sent to consignees for lot 60866613 to quarantine and return the product. On December 2, 2009 an e-mail was sent to U.S. distributors, and on December 3, 2009 and e-mail was sent to international distributors, instructing them to suspend usage and return all lots of size 8 trays. On December 9, 2009, a recall letter was sent to U.S. user accounts who received the products directly from Zimmer, U.S. distributors and Zimmer's U.S. sales force informing them of the recall. Direct questions about this recall to Zimmer, Inc. by calling 1-800-613-6131.
Quantity in commerce: 846
Distribution: Worldwide Distribution -- United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Saudi Arabia, Spain, Sweden, Switzerland and the United Kingdom.
Product codes and lots: All lots. Lots 00111134, 60747593, 60747594, 60752676, 60752677, 60760248, 60768076, 60821507, 60824004, 60830411, 60830412, 60845351, 60850604, 60852670, 60852671, 60860895, 60866613, 60872311, 60879050, 60892605, 60900745, 60907449, 60917234, 60922494, 60938889, 60938890, 60947027, 60947028, 60963035, 60963036, 60963037, 60963039, 60983254, 61015851, 61028168, 61033723, 61033724, 61068387, 61068388, 61068389, 61074754, 61074755, 61084771, 61096604, 61116246, 61116247, 61137056, 61143427, 61149041, 61157940, 61173295, 61193516, 61193520, 61198179, 61204038, 61215644, 61225562, 61235612, 61240323, 61248321, 61259184, 61263170, 61272449, 61285508, 61298201, 61306497, 61280371, 61315873, 61319581 and 61329266.

Product code JWH

K072160Class IINexgen Trabecular Metal Tibial TrayZimmer, Inc. / cleared 2007-09-05

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)