Recall Z-1972-2010 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Starion Instruments
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.
| Date | Jul 9, 2010 (initiated Jun 26, 2008) |
| Status | Terminated |
| Reason | Due to an improper fixture revision, device may be missing a screw at the jaw assembly, resulting in jaw components falling off during use. |
| Root cause | Process control |
| 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. |
| Quantity | 217 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062257 | STARION INSTRUMENTS THERMAL LITIGATING SHEARS Starion Instruments, Oct 10, 2006 |