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U.S. Department of Health and Human Services

Class 2 Device Recall Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears

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 Class 2 Device Recall Starion Instruments Real Hand ThermaSeal Thermal Ligating Shearssee related information
Date Initiated by FirmJune 26, 2008
Date PostedJuly 09, 2010
Recall Status1 Terminated 3 on October 27, 2010
Recall NumberZ-1972-2010
Recall Event ID 55750
510(K)NumberK062257 
Product Classification electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductStarion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments, Sunnyvale, CA Intended use: Medical Device used for cutting and cauterization of soft tissue during surgery, and of natural or synthetic, non-metallic sutures during surgery.
Code Information Model Number N-10700, lot numbers 80419, 806009, 804037, 804035, 804036, 804019A.
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		Due to an improper fixture revision, device may be missing a screw at the jaw assembly, resulting in jaw components falling off during use.
FDA Determined
Cause 2		Process control
ActionThe firm submitted an MDR but determined that there was no risk to health. E-mails were sent on June 26, 2008, to consignees, describing the product, the problem, and action to be taken by consignees. The consignees were ask to provide a list of all unused ThermaSeal devices and their locations, to return the products to Starion from the lots noted and to provide a copy of the attached letter to their sales force and customers if they choose. If you have any questions, please call (408) 522-5200 ext. 326 or (408) 350-9934.
Quantity in Commerce217 units
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.
510(K) Database510(K)s with Product Code = GEI
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