Recall Z-0609-2017 ยท HWC Screw, Fixation, Bone
Trilliant Surgical Ltd.
Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29 Trilliant Surgical, LTD"
| Date | Nov 17, 2016 (initiated Sep 2, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 11 |
| Distribution | CA, AZ, WI, FL, NJ, OH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112737 | TIGER HEADLESS CANNULATED SCREWS Trilliant Surgical, Ltd., Oct 20, 2011 |