Z-2301-2008

Zimmer NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor (a pounding instrument...

Name: Z-2301-2008 Zimmer NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor (a pounding instrument...
Creator: Zimmer Inc.
Published: 2008-06-30
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-06-30 / Terminated / root cause: design

FDA source

Zimmer Inc. began a recall of Zimmer NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor (a pounding instrument used during knee surgery), nonsterile, Zimmer... on 2008-06-30. The reason FDA records is "The instrument may fracture during use, resulting in metal fragments being left in the patient post-surgery, which could cause implant failure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2301-2008
Status: Terminated
Initiated: 2008-06-30
Posted: 2008-09-20
Terminated: 2009-11-12
Recalling firm: Zimmer GmbH
Product: Zimmer NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor (a pounding instrument used during knee surgery), nonsterile, Zimmer, Warsaw, Indiana; REF 5951-90..
Product code: HWA Impactor
Reason for recall: The instrument may fracture during use, resulting in metal fragments being left in the patient post-surgery, which could cause implant failure.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were notified via letter dated 6/30/08. The letter described the issue, provided instructions for the return of the product and asked customers to complete a reply back form. For assistance, contact Zimmer at 1-574-372-4487.
Quantity in commerce: 1439
Distribution: Nationwide, Australia, China, England, France, Germany, India, Italy, Japan, Korea, Singapore and Taiwan.
Product codes and lots: All units.

Product code HWA

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)