Date Initiated by Firm |
February 06, 2008 |
Date Posted |
July 08, 2010 |
Recall Status1 |
Terminated 3 on November 27, 2010 |
Recall Number |
Z-1969-2010 |
Recall Event ID |
55721 |
Product Classification |
electrosurgical, cutting, coagulation, accessories - Product Code GEI
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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 CA 94085-2915
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For Additional Information Contact |
408-522-5200 Ext. 317
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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.
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FDA Determined Cause 2 |
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
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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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