BEUDAMED
    FDA Enforcement Class II Terminated

    Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM 3) XL-105916 588500 RingLoc Hip System, Acetabular Liner, 36 MM, Size 26 Product Usage: Hemi hip arthroplasty.

    Recall: Z-2145-2020 · Reported June 3, 2020

    Enforcement

    Recall Number
    Z-2145-2020
    Event ID
    85524
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 3, 2020
    Initiation Date
    April 17, 2020
    Classification Date
    May 28, 2020
    Termination Date
    June 25, 2021
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM 3) XL-105916 588500 RingLoc Hip System, Acetabular Liner, 36 MM, Size 26 Product Usage: Hemi hip arthroplasty.

    Reason

    Potential presence of elevated endotoxin levels that exceed the specification limit

    Code Info

    Lot Numbers: UDI Number 1) 752470 (01)00880304568785(17)220118(10)752470 854070 (01)00880304568785(17)220119(10)854070; 2) 094360 (01)00880304209688(17)220106(10)094360; 3) 588500 (01)00880304209688(17)220106(10)094360

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.

    Quantity

    58 units