FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer M/G Unicompartmental Knee System headed screw, 48 mm length, sterile, Catalog No. 00-5791-041-00. Used during surgery for the cutting guide. This screw is not permanently implanted.
- Recall number
- Z-2300-2008
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer M/G Unicompartmental Knee System headed screw, 48 mm length, sterile, Catalog No. 00-5791-041-00. Used during surgery for the cutting guide. This screw is not permanently implanted.
- Status
- Terminated
- Initiated
- 2008-06-30
- Posted
- 2008-09-17
- Terminated
- 2008-12-17
- Reason
- An impurity in the metal may affect the strength of the screw, resulting in breakage and/or surgical delays.
- Root cause
- Nonconforming Material/Component
- Action
- Zimmer instructed consignees by a letter, dated June 30, 2008, sent via mail or email, to return the product.
- Quantity
- 5
- Distribution
- Florida, China and India.
- Lot, serial or model codes
- Lot 60954069.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1000220733
- 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