Device product
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"
Z-0609-2017
Product summary
- Event
- Event 75187
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11
- Official record key
device-enforcement:Z-0609-2017
Official wording
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.
Code information: Lot TSL003721
Distribution pattern: CA, AZ, WI, FL, NJ, OH
Derived failure modes
-
Unknown
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.