FDA Medical Device Recalls (openFDA)
Depuy Orthopaedics, Inc.: Depuy brand LCS Complete metal backed patella, porocoat, LRG+; REF 1294-09-670.
- Recall number
- Z-1027-05
- Recalling firm
- Depuy Orthopaedics, Inc.
- Product
- Depuy brand LCS Complete metal backed patella, porocoat, LRG+; REF 1294-09-670.
- Status
- Terminated
- Initiated
- 2005-06-07
- Posted
- 2005-07-21
- Terminated
- 2006-05-02
- Reason
- There may be dissociation of the polyethylene from the baseplate because the inside diameter of the polyethylene articular bearing was manufactured to an oversized condition.
- Root cause
- Other
- Action
- Hospitals were notified via letter dated June 10, 2005 requesting that they quarantine product on hand and send in a response card to the firm.
- Quantity
- not on file
- Distribution
- Nationwide and international.
- Lot, serial or model codes
- Lot 1851632.
- 510(k) numbers
- not on file
- PMA numbers
- ["P830055/R44"]
- 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