BEUDAMED
    FDA Recall Terminated

    Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)

    Recall: Z-1122-2015 · Initiated January 9, 2015

    Recall

    Recall Number
    Z-1122-2015
    Event Number
    70438
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    January 9, 2015
    Posted
    February 17, 2015
    Terminated
    October 22, 2015
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)

    Reason

    Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.

    Action

    Biomet notified all domestic and foreign customers via FEDEx overnight on 1/9/2015. Response forms were provided, customers were instructed to notify hospital personnel if product was further distributed, and remove recalled products from circulation. Replacement parts were made available, customers may contact Audrey Daenzer, Field Action Specialist, Regulatory Compliance Biomet, Inc., [email protected], or 574-372-1570 Monday- Friday 8 AM to 5 PM.

    Distribution

    Distributed in the states of VA and TX and the country of Japan.

    Quantity

    17