BEUDAMED
    FDA Enforcement Class II 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 · Reported April 10, 2019

    Enforcement

    Recall Number
    Z-1087-2019
    Event ID
    82332
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 10, 2019
    Initiation Date
    March 1, 2019
    Classification Date
    April 4, 2019
    Termination Date
    May 27, 2020
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    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.

    Code Info

    Lot Numbers/UDI Number 859960 (01) 00880304008700 (17) 280809 (10) 859960 859980 (01) 00880304008700 (17) 280805 (10) 859980 860120 (01) 00880304008700 (17) 280806 (10) 860120 860310 (01) 00880304008700 (17) 280823 (10) 860310 860580 (01) 00880304008700 (17) 280807 (10) 860580

    Distribution

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

    Quantity

    809 units total