BEUDAMED
    FDA Recall Terminated

    SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.

    Recall: Z-0585-2016 · Initiated December 1, 2015

    Recall

    Recall Number
    Z-0585-2016
    Event Number
    72774
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    HTO
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    December 1, 2015
    Posted
    January 5, 2016
    Terminated
    August 26, 2016
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.

    Reason

    The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm.

    Action

    On Dec 1, 2015, Synthes issued a recall notification letter and requested that all consignees review inventory and contact Synthes for a return authorization number. The verification form is to be completed and sent to Stericycle.

    Distribution

    US nationwide distibution.

    Quantity

    65