Starion 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.
FDA Recall Z-1972-2010 · Posted 2010-07-09
Recalling FirmStarion Instruments
Recall StatusTerminated
Product CodeGEI
Date Initiated2008-06-26
Date Terminated2010-10-27
Product Quantity217 units
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.
Firm Action
The 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.
Root Cause
Process control
Distribution Pattern
Worldwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.