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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 Device Recall Starion Instruments TLS3 35C Thermal Ligating Shearssee related information
Date Initiated by FirmFebruary 06, 2008
Date PostedJuly 08, 2010
Recall Status1 Terminated 3 on November 27, 2010
Recall NumberZ-1969-2010
Recall Event ID 55721
Product Classification electrosurgical, cutting, coagulation, accessories - Product Code GEI
ProductStarion 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
FEI Number 1000137656
Recalling Firm/
Manufacturer		 Starion Instruments
775 Palomar Ave
Sunnyvale CA 94085-2915
For Additional Information Contact
408-522-5200 Ext. 317
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		Nonconforming Material/Component
ActionThe 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
DistributionWorldwide distribution
Total Product Life CycleTPLC 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.
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