Z-1262-2009

Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach, Size 7, 8, nonsterile; REF 5997-61-07. A...

Name: Z-1262-2009 Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach, Size 7, 8, nonsterile; REF 5997-61-07. A...
Creator: Zimmer Inc.
Published: 2009-03-13
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-03-13 / Terminated / root cause: sterility

FDA source

Zimmer Inc. began a recall of Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach, Size 7, 8, nonsterile; REF 5997-61-07. A reusable cutting instrument that is used in total... on 2009-03-13. The reason FDA records is "The surface finish inside of the broach is not to specification and the instrument may corrode if cleaned and sterilized according to instructions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1262-2009
Status: Terminated
Initiated: 2009-03-13
Posted: 2009-05-12
Terminated: 2009-12-22
Recalling firm: Zimmer GmbH
Product: Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach, Size 7, 8, nonsterile; REF 5997-61-07. A reusable cutting instrument that is used in total knee arthroplasty surgery.
Product code: HTQ Broach
Reason for recall: The surface finish inside of the broach is not to specification and the instrument may corrode if cleaned and sterilized according to instructions.
Root cause tag: sterility
FDA root cause: Finished device change control
Action: Distributors were notified by an "Urgent: Device Recall" letter dated March 13, 2009. The letter described the affected product, reason for recall, health risks and actions for distributors and user facilities. Customers were instructed to quarantine affected instruments and return them to the Zimmer Product Service Department. Distributors were also instructed to provide the name and address of hospitals where the instruments were used so that a copy of the recall letter can be forwarded to the user facilities. Direct questions about this recall to Zimmer, Inc. by calling 800-613-6131.
Quantity in commerce: 37
Distribution: Worldwide Distribution -- US, Australia, and Germany.
Product codes and lots: Lot Number 61075338.

Product code HTQ

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)