Class 3 Device Recall Galileo Femoral Clamp

• Date Initiated by Firm: June 20, 2006
• Date Posted: November 08, 2006
• Recall Status: Terminated on December 13, 2007
• Recall Number: Z-0149-2007
• Recall Event ID: 36234
• 510(K)Number: K020298
• Product Classification: Femoral Clamp - Product Code HAW
• Product: Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226
• Code Information: All units
• Recalling Firm/ Manufacturer: Plus Orthopedics USA; 10188 Telesis Ct; San Diego CA 92121-4779
• For Additional Information Contact: Clint Corona; 888-741-7587 Ext. 2511
• Manufacturer Reason for Recall: Manufacturer recall of the device due to the possibility of pressure plate fractures/breakage.
• FDA Determined 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 in Commerce: 31
• Distribution: Nationwide including states of AZ, CA, CO, ID, NY, TX, VA & WI
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HAW