FDA Medical Device Recalls (openFDA)
Depuy Orthopaedics, Inc.: Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 2.5, 20.0 mm; Ref 96-0524.
- Recall number
- Z-1216-05
- Recalling firm
- Depuy Orthopaedics, Inc.
- Product
- Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 2.5, 20.0 mm; Ref 96-0524.
- Status
- Terminated
- Initiated
- 2005-05-26
- Posted
- 2005-08-12
- Terminated
- 2005-12-02
- Reason
- An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- Root cause
- Other
- Action
- not on file
- Quantity
- 23
- Distribution
- Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.
- Lot, serial or model codes
- Lots 83138A and 86064A.
- 510(k) numbers
- not on file
- PMA numbers
- ["P830055S084"]
- Product code
- NJL
- 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