Z-0885-2009

Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular surface, Size Blue, 14...

Name: Z-0885-2009 Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular surface, Size Blue, 14...
Creator: Zimmer Inc.
Published: 2008-12-12
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-12-12 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular surface, Size Blue, 14 MM Height, nonsterile, Zimmer, Warsaw, IN; REF... on 2008-12-12. The reason FDA records is "Some 12 mm thick devices may have been etched and packaged as 14 mm thick, and vice versa". 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-0885-2009
Status: Terminated
Initiated: 2008-12-12
Posted: 2009-01-23
Terminated: 2009-11-12
Recalling firm: Zimmer GmbH
Product: Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular surface, Size Blue, 14 MM Height, nonsterile, Zimmer, Warsaw, IN; REF 5971-50-14. Used during total knee arthroplasty surgery to determine the required thickness of the tibial bearing surface to be implanted. Reusable, non-implantable.
Product code: HWT Template
Reason for recall: Some 12 mm thick devices may have been etched and packaged as 14 mm thick, and vice versa.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Zimmer sales force and distribution sites were notified of the recall via email on 12/15/08 and instructed to inventory, return the affected products and to provide a copy of the recall letter to those customers to whom they had further distributed the products. The 'Urgent: Device Recall" letter dated 12/12/08, described the problem and the potential risks. For additional information, contact Zimmer, Inc., at 1-800-613-6131.
Quantity in commerce: 131 of both products.
Distribution: Nationwide, Canada, Denmark, Finland, Germany, Poland, Spain, Sweden and United Kingdom.
Product codes and lots: Lots 60969810 and 60969811.

Product code HWT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)