Z-2466-2008

FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore...

Name: Z-2466-2008 FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore...
Creator: Encore Medical, Lp
Published: 2008-08-04
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2008-08-04 / Terminated / root cause: design

FDA source

Encore Medical, Lp began a recall of FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed... on 2008-08-04. The reason FDA records is "Complaints received regarding the fracture of the Nitronic 60 screw on the Tibial Fixed Impactor during surgery". 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-2466-2008
Status: Terminated
Initiated: 2008-08-04
Posted: 2008-09-29
Terminated: 2009-08-03
Recalling firm: Encore Medical, LP
Product: FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed Impactor, a part of the FOUNDATION KNEE SYSTEM, is a manual orthopedic surgical instrument intended to lock onto the baseplate to impact the implant.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Complaints received regarding the fracture of the Nitronic 60 screw on the Tibial Fixed Impactor during surgery.
Root cause tag: design
FDA root cause: Device Design
Action: Recall notification sent via letter starting on 08/04/07. Consignees asked to quarantine and return affected devices. Contact Encore Medical, Lp at 1-512-834-6330 for assistance.
Quantity in commerce: 68 units.
Distribution: FL and TX and OUS: Japan.
Product codes and lots: All Revision A and Revision B Impactors.

Product code JWH

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)