FDA Medical Device Recalls (openFDA)
Depuy Orthopaedics, Inc.: Depuy P.F.C. Modular Knee System, constrained tibial insert (CONST); polyethylene tibial insert, Sz 6, 12.5 mm; Ref 98-6571.
- Recall number
- Z-1359-05
- Recalling firm
- Depuy Orthopaedics, Inc.
- Product
- Depuy P.F.C. Modular Knee System, constrained tibial insert (CONST); polyethylene tibial insert, Sz 6, 12.5 mm; Ref 98-6571.
- 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
- 5
- Distribution
- Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.
- Lot, serial or model codes
- Lot 86667A.
- 510(k) numbers
- not on file
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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