BEUDAMED
    FDA Recall 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 · Initiated September 2, 2016

    Recall

    Recall Number
    Z-0609-2017
    Event Number
    75187
    Firm
    Trilliant Surgical Ltd.
    FEI Number
    3007420745
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 2, 2016
    Posted
    November 17, 2016
    Terminated
    May 19, 2017
    Address
    6721 Portwest Dr, Ste 160, Houston, TX, 77024-8019

    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.

    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.

    Distribution

    CA, AZ, WI, FL, NJ, OH

    Quantity

    11