Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100.
FDA device recall Z-0057-2007 · posted 2006-10-21 · Terminated
Recall details
- Recalling firm
- Depuy Orthopaedics, Inc.
- Reason for recall
- Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 9
- Distribution
- Nationwide.
- Date initiated
- 2006-09-14
- Date posted
- 2006-10-21
- Date terminated
- 2007-04-26
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
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| P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) (K961685) | Johnson & Johnson Professionals, Inc. | 1996-07-10 |