Z-1369-04

P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703

Name: Z-1369-04 P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703
Creator: Depuy Orthopaedics, Inc.
Published: 2003-12-22
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2003-12-22 / Terminated

FDA source

Depuy Orthopaedics, Inc. began a recall of P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703 on 2003-12-22. The reason FDA records is "The collar was incorrectly etched for the R (right) and L (Left) orientation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1369-04
Status: Terminated
Initiated: 2003-12-22
Posted: 2004-08-24
Terminated: 2004-09-23
Recalling firm: Depuy Orthopaedics Inc.
Product: P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The collar was incorrectly etched for the R (right) and L (Left) orientation
FDA root cause: Other
Action: Depuy notified distributors at the various territories via verbal contact on 12/23/2003
Quantity in commerce: 1 unit
Distribution: NY
Product codes and lots: Lot Number: 226436R

Product code JWH

K952830Class IIDarwin Knee System (Tc3)Johnson & Johnson Professionals, Inc. / cleared 1996-01-18

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)