Date Initiated by Firm | March 09, 2010 |
Date Posted | August 19, 2010 |
Recall Status1 |
Terminated 3 on November 27, 2010 |
Recall Number | Z-2239-2010 |
Recall Event ID |
55043 |
510(K)Number | K062257 |
Product Classification |
Electrosurgical, cutting/cauterization and accessories - Product Code GEI
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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 CA 94085-2915
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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 | 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 |
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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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510(K) Database | 510(K)s with Product Code = GEI
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