BEUDAMED
    FDA Recall Terminated

    DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43

    Recall: Z-1912-2016 · Initiated May 2, 2016

    Recall

    Recall Number
    Z-1912-2016
    Event Number
    74080
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    HTO
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    May 2, 2016
    Posted
    June 6, 2016
    Terminated
    December 13, 2016
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43

    Reason

    Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. The high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points. This could potentially be reproduced during use and reprocessing.

    Action

    Depuy Synthes sent an Urgent Notice: Medical Device Recall letter on 05/02/2016 to all affected consignees. Consignees were instructed to do the following: review your inventory immediately to see if any of the affected products were being stored, and call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement order, to complete the Verification Section (page 3) and return with the product to Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132.

    Distribution

    US nationwide distribution.

    Quantity

    244 units