BEUDAMED
    FDA Recall Terminated

    Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other small bones.

    Recall: Z-2087-2013 · Initiated July 30, 2013

    Recall

    Recall Number
    Z-2087-2013
    Event Number
    65890
    Firm
    Synthes USA HQ, Inc.
    FEI Number
    3005180112
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 30, 2013
    Posted
    August 26, 2013
    Terminated
    May 21, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other small bones.

    Reason

    The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are etched with "R" for right plate when they should be etched with "L" for left plate.

    Action

    Synthes GMBH sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory and immediately remove the affected product from stock. Customers were advised to complete the Verification Section at the end of the letter. For questions call 610-719-5450 or contact your Synthes Sales Consultant.

    Distribution

    USA Nationwide Distribution in the states of FL, GA, NC, OH, KY, NJ, ID, IN, and MN.

    Quantity

    11