Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32… recallZ-0057-2007 · Depuy Orthopaedics, Inc. · initiated Sep 14, 2006
Terminated All recalls posted in October 2006
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
Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella.
FDA root cause category: Other
What the company is doing
The firm called their sales staff on 9/14/06 and instructed them to place a hold on the product, which entails pulling products from their own inventory and at any hospitals where it has been placed on consignment. Sales staff immediately visited hospital accounts and switched out the recalled lot for other product.
Recall details
- Recall number
- Z-0057-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 14, 2006
- Posted by the FDA
- Oct 21, 2006
- Recalling firm
- Depuy Orthopaedics, Inc.
- Quantity
- 9
- Product code
- JWH
- FDA submissions
- K961685
- Distribution
- Nationwide.
Product description
Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100.
Code information (models, lots, serial numbers)
Lot 2203528.
Other devices under the same FDA submission
34 devices cleared under K961685 — 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. SIGMA 86-4182Depuy Orthopaedics, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- P.F.C. SIGMA 86-4177Depuy Orthopaedics, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- P.F.C. SIGMA 86-4180Depuy Orthopaedics, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- P.F.C. SIGMA 86-4183Depuy Orthopaedics, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- P.F.C. SIGMA 1581-04-008Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- P.F.C. SIGMA 1581-04-010Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- P.F.C. SIGMA 96-0640Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- P.F.C. SIGMA 96-0650Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- P.F.C. SIGMA 96-0660Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- P.F.C. SIGMA 96-2630Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- SIGMA 96-0017Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- P.F.C. SIGMA 96-0642Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
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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