Recall Z-0149-2007 ยท HAW Neurological Stereotaxic Instrument
Plus Orthopedics USA
Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226
| Date | Nov 8, 2006 (initiated Jun 20, 2006) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020298 | GALILEO CAS/NAV TKR SYSTEM Plus Orthopedics, May 20, 2002 |