Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-7
FDA device recall Z-0609-2017 · posted 2016-11-17 · Terminated
Recall details
- Recalling firm
- Trilliant Surgical Ltd.
- Reason for recall
- Screws were identified as having the incorrect part number and lot number marked upon them. The part number incorrectly indicated a length of 115 mm rather than 110 mm. The lot number incorrectly indicated lot number of TSL003765 rather than TSL003721.
- Action taken
- The firm sent out written notifcation of the recall on 9/2/16; the letter instructed the consignees to discontinue use of the affected lot, quarantine, and return product of the affected lot in accordance with an included acknowledgement sheet.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 11
- Distribution
- CA, AZ, WI, FL, NJ, OH
- Date initiated
- 2016-09-02
- Date posted
- 2016-11-17
- Date terminated
- 2017-05-19
- Location
- Houston, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TIGER HEADLESS CANNULATED SCREWS (K112737) | Trilliant Surgical, Ltd. | 2011-10-20 |