FDA Enforcement
Class II
Terminated
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"
Recall: Z-0609-2017
·
Reported November 23, 2016
Enforcement
- Recall Number
- Z-0609-2017
- Event ID
- 75187
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Trilliant Surgical Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 23, 2016
- Initiation Date
- September 2, 2016
- Classification Date
- November 17, 2016
- Termination Date
- May 19, 2017
- Address
- 6721 Portwest Dr Ste 160, N/A, Houston, TX, 77024-8019, United States
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
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 Info
Lot TSL003721
Distribution
CA, AZ, WI, FL, NJ, OH
Quantity
11