Starion Instruments TLS3 35C Thermal Ligating Shears, Electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments Corp, Sunnyvale, CA. Intended use: medical device for use in cutting and cauterization of soft tissue during surgery, as well as cutting of natural or synthetic, non-metallic sutures during surgery.
Recall
- Recall Number
- Z-1969-2010
- Event Number
- 55721
- Firm
- Starion Instruments
- FEI Number
- 1000137656
- Product Code
- GEI
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- February 6, 2008
- Posted
- July 8, 2010
- Terminated
- November 27, 2010
- Address
- 775 Palomar Ave, Sunnyvale, CA, 94085-2915
Description
Starion Instruments TLS3 35C Thermal Ligating Shears, Electrosurgical cutting and coagulation device and accessories, manufactured by Starion Instruments Corp, Sunnyvale, CA. Intended use: medical device for use in cutting and cauterization of soft tissue during surgery, as well as cutting of natural or synthetic, non-metallic sutures during surgery.
Some jaws exhibited lack of ductility and could break if overloaded or used improperly by placing too much tissue in the bottom of the "v" of the jaw.
The firm called domestic consignees but no letter was sent to domestic cosignees and a notification letter was sent to international consignees. The firm called domestic consignees and sent a notification letter to international consignees. No records were kept of phone calls and a copy of the letter sent to international consignees was not obtained
Worldwide distribution