BEUDAMED
    FDA Recall Terminated

    Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage: Accessory to total hip implant

    Recall: Z-1087-2019 · Initiated March 1, 2019

    Recall

    Recall Number
    Z-1087-2019
    Event Number
    82332
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    March 1, 2019
    Terminated
    May 27, 2020
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Product Usage: Accessory to total hip implant

    Reason

    Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.

    Action

    Zimmer Biomet conducted recall by letter dated 3/1/19 to the consumer/user level, including any intermediate wholesale or retail consignees. All distributors via email. Hospital risk managers and surgeons, as well as distributors with product notified Fed'x. Accounts asked to review notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory.3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.a. Complete Attachment 1 Inventory Return Certification Form. Questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.

    Distribution

    Worldwide Distribution - US Nationwide Foreign: CHILE CHINA COSTA RICA GUJRAT,INDIA JAPAN MEXICO CDMX SINGAPORE

    Quantity

    809 units total