FDA Medical Device Recalls (openFDA)
Depuy Orthopaedics, Inc.: P.F.C. Modular Knee System Modular Plus Tibial Wedge 10 HEMI x 8.5MM HEIGHT Product Code: 86-0178
- Recall number
- Z-1382-04
- Recalling firm
- Depuy Orthopaedics, Inc.
- Product
- P.F.C. Modular Knee System Modular Plus Tibial Wedge 10 HEMI x 8.5MM HEIGHT Product Code: 86-0178
- Status
- Terminated
- Initiated
- 2004-01-15
- Posted
- 2004-08-24
- Terminated
- 2004-09-23
- Reason
- Screw size included in system was incorrect
- Root cause
- Other
- Action
- DePuy notified the sales territories via verbal contact with the distributors on 1/15/04.
- Quantity
- 1 unit
- Distribution
- IA
- Lot, serial or model codes
- Lot Umber: 330722
- 510(k) numbers
- ["K923807"]
- 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