BEUDAMED
    FDA Recall Terminated

    CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE Orthopedic

    Recall: Z-2602-2014 · Initiated July 30, 2014

    Recall

    Recall Number
    Z-2602-2014
    Event Number
    69058
    Firm
    Wright Medical Technology, Inc.
    FEI Number
    3010667733
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 30, 2014
    Posted
    September 8, 2014
    Terminated
    June 15, 2018
    Address
    1023 Cherry Rd, Memphis, TN, 38117-5423

    Description

    CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE Orthopedic

    Reason

    Plates manufactured from an incorrect raw material.

    Action

    Wright Medical sent an Urgent Medical Device Recall letter dated July 25, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for the affected product and immediately quarantine all affected product and return to Wright Medical as soon as possible. For return instructions customers were instructed to contact Customer Service at 800-238-7117. Customers were also asked to complete the attached response form, confirming receipt of the notice and the status of the product(s) on hand and return by fax to 901-867-7401. Customers with questions were instructed to call 901-290-5662. For questions regarding this recall call 800-238-7117.

    Distribution

    Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.

    Quantity

    1127 units