Z-1069-03

Foundation Knee System, non-porous Femur Size 8, Right

Name: Z-1069-03 Foundation Knee System, non-porous Femur Size 8, Right
Creator: Encore Medical, LP
Published: 2003-04-24
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2003-04-24 / Terminated / root cause: labeling and UDI

FDA source

Encore Medical, LP began a recall of Foundation Knee System, non-porous Femur Size 8, Right on 2003-04-24. The reason FDA records is "Product container was labeled incorrectly indicating left femur instead of right". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1069-03
Status: Terminated
Initiated: 2003-04-24
Posted: 2003-07-30
Terminated: 2003-07-29
Recalling firm: Encore Medical, LP
Product: Foundation Knee System, non-porous Femur Size 8, Right
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Product container was labeled incorrectly indicating left femur instead of right.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm recalled non-implanted devices. The firm initiated the recall on 04/23/2003 via phone to sales representatives and foreign distributors.
Quantity in commerce: 14 unimplanted units
Distribution: PA, TX, MA, FL, NV, AZ, and France and Saudi Arabia
Product codes and lots: Lot numbers 811761, 815241, 815251, 817891, 834781, 835291, 838201, 850611

Product code JWH

K923277Class IIFoundation Knee SystemEncore Orthopedics, Inc. / cleared 1993-02-09

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)