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U.S. Department of Health and Human Services

Class 3 Device Recall Galileo Femoral Clamp

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  Class 3 Device Recall Galileo Femoral Clamp see related information
Date Initiated by Firm June 20, 2006
Date Posted November 08, 2006
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = PLUS ORTHOPEDICS
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