The Starion Instruments Thermal Ligating Shears 35C Model 102-138D and 23C Model numbers 102-137D allow the surgeon to p
FDA device recall Z-2239-2010 · posted 2010-08-19 · Terminated
Recall details
- Recalling firm
- Starion Instruments
- Reason for recall
- The Starion Instruments Thermal Ligating Shears (STLS) 35C and the Starion Thermal Ligating Shears (STLS) 23C may turn on and remain on without the finger button being depressed. The devices may also work intermittently, incorrectly indicating the device is 'on".
- Action taken
- Starion distributed a "STLS Device Recall - Important Medical Device Information" letter dated March 9, 2010 to consignees. The letter identified the affected model and lot numbers. Consignees were asked to complete a inventory status form and fax to Starion. the letter included a shipping labe with a pre-assigned return authorization number. Starion will ship replacement after receipt of the inventory status form and returned product..
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 228 units
- Distribution
- Worldwide Distribution: USA states of CA, OH, MI, KS and MO and countries of Italy, China, Kuwait, and Germany.
- Date initiated
- 2010-03-09
- Date posted
- 2010-08-19
- Date terminated
- 2010-11-27
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STARION INSTRUMENTS THERMAL LITIGATING SHEARS (K062257) | Starion Instruments | 2006-10-10 |