Z-0119-2011

NexGen Complete Knee Solution Stemmed Tibial Component Precoat Size 6, REF 00-5980-047-02, Sterile, Zimmer...

Name: Z-0119-2011 NexGen Complete Knee Solution Stemmed Tibial Component Precoat Size 6, REF 00-5980-047-02, Sterile, Zimmer...
Creator: Zimmer Inc.
Published: 2010-01-26
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2010-01-26 / Terminated / root cause: manufacturing process

FDA source

Zimmer Inc. began a recall of NexGen Complete Knee Solution Stemmed Tibial Component Precoat Size 6, REF 00-5980-047-02, Sterile, Zimmer, Warsaw, IN. Intended for mating with a UHMWPE... on 2010-01-26. The reason FDA records is "Zimmer had determined that two lots of these tibial implants have incorrectly positioned or missing flange plugs that were not seated in the device upon receipt to the customer. A missing flange plug could lead to a...". 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-0119-2011
Status: Terminated
Initiated: 2010-01-26
Posted: 2010-10-21
Terminated: 2010-10-23
Recalling firm: Zimmer GmbH
Product: NexGen Complete Knee Solution Stemmed Tibial Component Precoat Size 6, REF 00-5980-047-02, Sterile, Zimmer, Warsaw, IN. Intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component and is indicated for cemented use only.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Zimmer had determined that two lots of these tibial implants have incorrectly positioned or missing flange plugs that were not seated in the device upon receipt to the customer. A missing flange plug could lead to a delay of surgery or possibility of wear leading to more surgery.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm sent an URGENT MARKET WITHDRAWAL to its sales force and distributors on 1/26/2010. The letter identifies the affected product and explains the reason for the Market Withdrawal. The letter also explains the clinical implications and instructs consignees to locate any unused devices and quarantine them immediately. A physical count should be carried out of all affected devices and recorded on the Inventory Return Certification Form that's included with the letter. A copy of the letter should be faxed to Zimmer, Inc. and the affected product should be returned along with the form to the firm.
Quantity in commerce: 61 untis
Distribution: Worldwide Distribution -- US, Canada, Singapore Australia, and India.
Product codes and lots: Lot Number: 61246477.

Product code JWH

K933785Class IINext Generation Knee SystemZimmer, Inc. / cleared 1995-01-30

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)