Z-0609-2017 Class II Terminated
FDA device recall Z-0609-2017 was initiated by Trilliant Surgical Ltd. on September 2, 2016 and is designated Class II. 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 ind… The recall status is terminated (terminated May 19, 2017). Affected quantity: 11.
Recall Details
- Product Type
- Devices
- Report Date
- November 23, 2016
- Initiation Date
- September 2, 2016
- Termination Date
- May 19, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11
Product Description
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"
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.
Distribution Pattern
CA, AZ, WI, FL, NJ, OH
Code Information
Lot TSL003721