Z-1382-04

P.F.C. Modular Knee System Modular Plus Tibial Wedge 10 HEMI x 8.5MM HEIGHT

Name: Z-1382-04 P.F.C. Modular Knee System Modular Plus Tibial Wedge 10 HEMI x 8.5MM HEIGHT
Creator: Depuy Orthopaedics, Inc.
Published: 2004-01-15
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2004-01-15 / Terminated

FDA source

Depuy Orthopaedics, Inc. began a recall of P.F.C. Modular Knee System Modular Plus Tibial Wedge 10 HEMI x 8.5MM HEIGHT Product Code: 86-0178 on 2004-01-15. The reason FDA records is "Screw size included in system was incorrect". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1382-04
Status: Terminated
Initiated: 2004-01-15
Posted: 2004-08-24
Terminated: 2004-09-23
Recalling firm: Depuy Orthopaedics Inc.
Product: P.F.C. Modular Knee System Modular Plus Tibial Wedge 10 HEMI x 8.5MM HEIGHT Product Code: 86-0178
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Screw size included in system was incorrect
FDA root cause: Other
Action: DePuy notified the sales territories via verbal contact with the distributors on 1/15/04.
Quantity in commerce: 1 unit
Distribution: IA
Product codes and lots: Lot Umber: 330722

Product code JWH

K923807Class IIP.f.c. Modular Total Knee System, Modular PlusJohnson & Johnson International / cleared 1992-11-09

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)