BEUDAMED
    FDA Enforcement Class II Terminated

    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 320MM

    Recall: Z-0465-2018 · Reported February 7, 2018

    Enforcement

    Recall Number
    Z-0465-2018
    Event ID
    78763
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 7, 2018
    Initiation Date
    August 7, 2017
    Classification Date
    January 29, 2018
    Termination Date
    March 29, 2019
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 320MM

    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.

    Code Info

    Item No. 814511320; Lot No. (Exp. Date) UDI: 480090 (05/18/2027) UDI (01)00887868039140 (17)270518 (10)480090; 893410 (06/12/2027) UDI (01)00887868039140 (17)270612 (10)893410; 942070 (07/17/2027) UDI (01)00887868039140 (17)270717 (10)942070

    Distribution

    US nationwide distribution. Also Portugal and the Netherlands.

    Quantity

    638 units