BEUDAMED
    FDA Recall Terminated

    Optimus Fixed Awl

    Recall: Z-0891-2017 · Initiated November 22, 2016

    Recall

    Recall Number
    Z-0891-2017
    Event Number
    75856
    Firm
    Amendia, Inc
    FEI Number
    3007970248
    Product Code
    OVD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 22, 2016
    Posted
    December 22, 2016
    Terminated
    February 28, 2017
    Address
    1755 W Oak Pkwy, Marietta, GA, 30062-2260

    Description

    Optimus Fixed Awl

    Reason

    Complaints that the tip of the awl broke after impaction during surgery.

    Action

    Amendia Inc. sent an Urgent : Medical Device Recall letter dated November 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter requested that they examine inventory and quarantine the product. The letter also requested that they contact Amendia to confirm receipt of the letter and to obtain a Return Material Authorization for any product on hand. For further questions, please call (404) 610-7215.

    Distribution

    US Distribution to the states of : FL, GA. IL, MO, TX

    Quantity

    9 devices