BEUDAMED
    FDA Recall Terminated

    Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM

    Recall: Z-0422-2018 · Initiated August 7, 2017

    Recall

    Recall Number
    Z-0422-2018
    Event Number
    78763
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    August 7, 2017
    Terminated
    March 29, 2019
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM

    Reason

    During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

    Action

    Customers were notified via FedEx and/or email on approximately 08/07/2017. Instructions include ensure appropriate personnel are notified of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide the names of hospitals or customers that would have received this product if further distributed.

    Distribution

    US nationwide distribution. Also Portugal and the Netherlands.

    Quantity

    638 units