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.
Recall
- Recall Number
- Z-1972-2010
- Event Number
- 55750
- Firm
- Starion Instruments
- FEI Number
- 1000137656
- Product Code
- GEI
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- June 26, 2008
- Posted
- July 9, 2010
- Terminated
- October 27, 2010
- Address
- 775 Palomar Ave, Sunnyvale, CA, 94085-2915
Description
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.
Due to an improper fixture revision, device may be missing a screw at the jaw assembly, resulting in jaw components falling off during use.
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.
Worldwide distribution.
217 units