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U.S. Department of Health and Human Services

Class 2 Device Recall SPS Blue Line Tube Clamp Adapters

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  Class 2 Device Recall SPS Blue Line Tube Clamp Adapters see related information
Date Initiated by Firm October 03, 2006
Date Posted January 10, 2007
Recall Status1 Terminated 3 on March 07, 2008
Recall Number Z-0445-2007
Recall Event ID 36626
Product Classification Tube Clamp adapters - Product Code ISH
Product SPS Blue Line Tube Clamp Adapters, Product No. BL120M
Code Information Product number BL120M, with the letters, ''SPS'' etched into the product
Recalling Firm/
Southern Prosthetic Supply Co.
6025 Shiloh Rd Ste A
Alpharetta GA 30005-1706
For Additional Information Contact Eric Craig
Manufacturer Reason
for Recall
Device Fracturing: recent design and process changes leave the device susceptible to fracturing, which could cause the prosthesis to fail
FDA Determined
Cause 2
Action On October 6, 2006, SPS faxed a recall notification to the 187 customers who had purchased one or more BL120M Tube Clamp Adapters from SPS between August 29 and September 20, 2006. On October 9, SPS contacted those customers that had purchased five or more Adapters via telephone to confirm they had received the faxed recall notification. On October 10, SPS mailed another copy of the recall notification, via certified mail, return receipt requested to all of its customers that had purchased one or more BL120M Tube Clamp Adapters. The customers were told to send the BL120M Adapter back to SPS following replacement.
Quantity in Commerce 943 units
Distribution Nationwide
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.