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U.S. Department of Health and Human Services

Class 2 Device Recall Starion Instruments TLS3 35C Thermal Ligating Shears

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 Class 2 Recall
Starion Instruments TLS3 35C Thermal Ligating Shears
see related information
Date Posted July 08, 2010
Recall Status1 Terminated on November 27, 2010
Recall Number Z-1969-2010
Recall Event ID 55721
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product Starion Instruments TLS3 35C Thermal Ligating Shears, Electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments Corp, Sunnyvale, CA. Intended use: medical device for use in cutting and cauterization of soft tissue during surgery, as well as cutting of natural or synthetic, non-metallic sutures during surgery.
Code Information Model number 132-136D, lot numbers 708027 and 710008, expiration dates 09/21/12 and 10/19/12
Recalling Firm/
Manufacturer
Starion Instruments
775 Palomar Ave
Sunnyvale, California 94085-2915
Manufacturer Reason
for Recall
Some jaws exhibited lack of ductility and could break if overloaded or used improperly by placing too much tissue in the bottom of the "v" of the jaw.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The firm called domestic consignees but no letter was sent to domestic cosignees and a notification letter was sent to international consignees. The firm called domestic consignees and sent a notification letter to international consignees. No records were kept of phone calls and a copy of the letter sent to international consignees was not obtained.
Distribution Worldwide distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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