Depuy Orthopaedics, Inc. Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100.
Brand
Depuy Orthopaedics, Inc.
Lot Codes / Batch Numbers
Lot 2203528.
Products Sold
Lot 2203528.
Depuy Orthopaedics, Inc. is recalling Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100. due to Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026