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"
FDA Recall Z-0609-2017 · Posted 2016-11-17
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Recalling FirmTrilliant Surgical Ltd.
Recall StatusTerminated
Product CodeHWC
Date Initiated2016-09-02
Date Terminated2017-05-19
Product Quantity11
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
CA, AZ, WI, FL, NJ, OH
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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