Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226
FDA device recall Z-0149-2007 · posted 2006-11-08 · Terminated
Recall details
- Recalling firm
- Plus Orthopedics USA
- Reason for recall
- Manufacturer recall of the device due to the possibility of pressure plate fractures/breakage.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 31
- Distribution
- Nationwide including states of AZ, CA, CO, ID, NY, TX, VA & WI
- Date initiated
- 2006-06-20
- Date posted
- 2006-11-08
- Date terminated
- 2007-12-13
- Location
- San Diego, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GALILEO CAS/NAV TKR SYSTEM (K020298) | Plus Orthopedics | 2002-05-20 |