Starion Instruments Real Hand ThermaSeal Thermal Ligating Shears, electrosurgical cutting and coagulation device and acc
FDA device recall Z-1972-2010 · posted 2010-07-09 · Terminated
Recall details
- Recalling firm
- Starion Instruments
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 217 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2008-06-26
- Date posted
- 2010-07-09
- Date terminated
- 2010-10-27
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STARION INSTRUMENTS THERMAL LITIGATING SHEARS (K062257) | Starion Instruments | 2006-10-10 |