Z-0650-2007

NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide...

Name: Z-0650-2007 NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide...
Creator: Zimmer Inc.
Published: 2006-10-10
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2006-10-10 / Terminated

FDA source

Zimmer Inc. began a recall of NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures... on 2006-10-10. The reason FDA records is "The device was cut to an incorrect angle, which may result in an incorrect bone cut". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0650-2007
Status: Terminated
Initiated: 2006-10-10
Posted: 2007-03-28
Terminated: 2007-12-04
Recalling firm: Zimmer GmbH
Product: NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272521.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The device was cut to an incorrect angle, which may result in an incorrect bone cut.
FDA root cause: Other
Action: Product was removed from customer location during visit on 10/10/2006.
Quantity in commerce: 1
Distribution: One medical facility in Michigan.
Product codes and lots: Lot 97000417.

Product code JWH

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)