FDA Medical Device Recalls (openFDA)
Plus Orthopedics USA: Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226
- Recall number
- Z-0149-2007
- Recalling firm
- Plus Orthopedics USA
- Product
- Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226
- Status
- Terminated
- Initiated
- 2006-06-20
- Posted
- 2006-11-08
- Terminated
- 2007-12-13
- Reason
- Manufacturer recall of the device due to the possibility of pressure plate fractures/breakage.
- Root cause
- Other
- Action
- Notification will take place to the wholesale (agent) level via telephone calls from PLUS USA''s Customer Service Department on/or about June 20, 2006. Each location will be contacted to determine if they have any affected devices. If so, they will be issued an RMA with the request to return any affected devices as soon as possible. Returned devices will be sent to the manufacturer for repair.
- Quantity
- 31
- Distribution
- Nationwide including states of AZ, CA, CO, ID, NY, TX, VA & WI
- Lot, serial or model codes
- All units
- 510(k) numbers
- ["K020298"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 3001237832
- Firm city
- San Diego
- Firm state
- CA
- 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