BEUDAMED
    FDA Recall Terminated

    A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.

    Recall: Z-2072-2015 · Initiated June 17, 2015

    Recall

    Recall Number
    Z-2072-2015
    Event Number
    71549
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    HYA
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    June 17, 2015
    Posted
    July 14, 2015
    Terminated
    March 22, 2016
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.

    Reason

    Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Potential that the surgeon will be unable to provisionally clamp the plate to the patient's bone.

    Action

    On 6/17/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for locating and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

    Distribution

    Domestic: TX NJ, NC, KY, MA, SD, MO, AL, IN, GA, AR International: Netherlands, Japan, Costa Rica

    Quantity

    223