P.F.C. Modular Knee System recallZ-1382-04 · Depuy Orthopaedics, Inc. · initiated Jan 15, 2004
Terminated All recalls posted in August 2004
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Depuy Orthopaedics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Screw size included in system was incorrect
FDA root cause category: Other
What the company is doing
DePuy notified the sales territories via verbal contact with the distributors on 1/15/04.
Recall details
- Recall number
- Z-1382-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 15, 2004
- Posted by the FDA
- Aug 24, 2004
- Recalling firm
- Depuy Orthopaedics, Inc.
- Quantity
- 1 unit
- Product code
- JWH
- FDA submissions
- K923807
- Distribution
- IA
Product description
P.F.C. Modular Knee System Modular Plus Tibial Wedge 10 HEMI x 8.5MM HEIGHT Product Code: 86-0178
Code information (models, lots, serial numbers)
Lot Umber: 330722
Other devices under the same FDA submission
8 devices cleared under K923807 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- P.F.C. 86-0123Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- P.F.C. 86-0173Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- P.F.C. 86-0180Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- P.F.C. 86-0174Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- P.F.C. 86-0181Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- P.F.C. 86-0185Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- P.F.C. 86-0186Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- P.F.C. 86-0379Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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