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"
This recall has been terminated (originally issued November 17, 2016).
- Company
- Trilliant Surgical Ltd.
- Recall Initiated
- September 2, 2016
- Posted
- November 17, 2016
- Terminated
- May 19, 2017
- Recall Number
- Z-0609-2017
- Quantity
- 11
- Firm Location
- Houston, TX
- Official Source
- View on FDA website ↗
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
CA, AZ, WI, FL, NJ, OH
Lot / Code Info
Lot TSL003721
Root Cause
Nonconforming Material/Component
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.
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