FDA Medical Device Recalls (openFDA)
Depuy Orthopaedics, Inc.: Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100.
- Recall number
- Z-0057-2007
- Recalling firm
- Depuy Orthopaedics, Inc.
- Product
- Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100.
- Status
- Terminated
- Initiated
- 2006-09-14
- Posted
- 2006-10-21
- Terminated
- 2007-04-26
- Reason
- Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella.
- Root cause
- Other
- Action
- 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.
- Quantity
- 9
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot 2203528.
- 510(k) numbers
- ["K961685"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1818910
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28