FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer 4.5 Compression plate-broad, 10 hole, 167 MM length, stainless steel, non sterile, Manufactured at Zimmer; REF 4945-10-01. The product is used for stabilization of fractures during the normal healing process.
- Recall number
- Z-2179-2008
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer 4.5 Compression plate-broad, 10 hole, 167 MM length, stainless steel, non sterile, Manufactured at Zimmer; REF 4945-10-01. The product is used for stabilization of fractures during the normal healing process.
- Status
- Terminated
- Initiated
- 2008-06-09
- Posted
- 2008-09-11
- Terminated
- 2009-11-12
- Reason
- An impurity in the metal may affect the strength of the plate or biocompatibility of the material with the body.
- Root cause
- Material/Component Contamination
- Action
- Zimmer Thailand was notified via an emailed letter dated 6/9/08 to check for inventory at all customer accounts and to return the product. Contact Zimmer at 1-574-371-8028 for assistance.
- Quantity
- 7
- Distribution
- International Distribution --- including Thailand.
- Lot, serial or model codes
- Lot 60985554.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HRS
- 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