BEUDAMED
    FDA Enforcement Class II Terminated

    Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality

    Recall: Z-1741-2015 · Reported June 17, 2015

    Enforcement

    Recall Number
    Z-1741-2015
    Event ID
    71255
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 17, 2015
    Initiation Date
    May 1, 2015
    Classification Date
    June 9, 2015
    Termination Date
    December 8, 2015
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality

    Reason

    Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. This prevents complete range of motion and if pushed too far may loosen the pin from the bone. A revision surgery may be necessary to adequately reconnect the fixator to the bone.

    Code Info

    Part 14-450510 Lots:268000, 466170, and 813950

    Distribution

    US Nationwide Distribution in the states of CA, TX, FL, NC, MI, GA.

    Quantity

    19