BEUDAMED
    FDA Recall Terminated

    Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623

    Recall: Z-1758-2018 · Initiated April 2, 2018

    Recall

    Recall Number
    Z-1758-2018
    Event Number
    79850
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    GAD
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 2, 2018
    Terminated
    October 16, 2019
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623

    Reason

    There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.

    Action

    On April 2, 2018 Synthes (USA) LLC mailed an Urgent Product Recall notification letter to affected customers. Customers were instructed to: Review current inventory to identify and quarantine all affected products; Complete the Verification section of the Return Receipt form; Return affected product; Forward the notification to anyone in your facility that needs to be informed; If affected products have been forwarded to another facility, contact that facility to arrange return; Keep a copy of the notification. Customers with questions may call (610)719-5450 or contact your Depuy Synthese Sales Consultant.

    Distribution

    US Nationwide and Canada

    Quantity

    235