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U.S. Department of Health and Human Services

Class 2 Device Recall Starion Instruments Thermal Ligating Shears

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 Class 2 Recall
Starion Instruments Thermal Ligating Shears
see related information
Date Posted August 19, 2010
Recall Status1 Terminated on November 27, 2010
Recall Number Z-2239-2010
Recall Event ID 55043
Premarket Notification
510(K) Number
K062257 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product The Starion Instruments Thermal Ligating Shears 35C Model 102-138D and 23C Model numbers 102-137D allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. The surgeon squeezes the handle and depresses the switch, heating elements activates in the jaws. The heat is conducted to the tissue between the jaws to provide cutting/cauterization. For the simultaneous cutting and cauterization of soft tissue during surgery. Cutting of natural or synthetic, non-metallic, sutures during surgery.
Code Information STLS 23C: Model numbers 102-137D, Lot Numbers: 905029, 907007, 910016, 908022 STLS 35C: Model 102-138D, Lot Numbers: 907004 and 907008
Recalling Firm/
Manufacturer
Starion Instruments
775 Palomar Ave
Sunnyvale, California 94085-2915
For Additional Information Contact Tom McGaffigan
408-522-5200 Ext. 311
Manufacturer Reason
for Recall
The Starion Instruments Thermal Ligating Shears (STLS) 35C and the Starion Thermal Ligating Shears (STLS) 23C may turn on and remain on without the finger button being depressed. The devices may also work intermittently, incorrectly indicating the device is 'on".
FDA Determined
Cause 2
DESIGN: Device Design
Action Starion distributed a "STLS Device Recall - Important Medical Device Information" letter dated March 9, 2010 to consignees. The letter identified the affected model and lot numbers. Consignees were asked to complete a inventory status form and fax to Starion. the letter included a shipping labe with a pre-assigned return authorization number. Starion will ship replacement after receipt of the inventory status form and returned product..
Quantity in Commerce 228 units
Distribution Worldwide Distribution: USA states of CA, OH, MI, KS and MO and countries of Italy, China, Kuwait, and Germany.
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.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = STARION INSTRUMENTS
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