FDA Device

Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226

Hazard

Manufacturer recall of the device due to the possibility of pressure plate fractures/breakage.

What You Should Do

Remedy

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.

Products

Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226
Brand
Plus Orthopedics USA
UPC
All units

Units Affected

31