BEUDAMED
    FDA Recall Terminated

    A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.

    Recall: Z-2046-2015 · Initiated June 4, 2015

    Recall

    Recall Number
    Z-2046-2015
    Event Number
    71511
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    June 4, 2015
    Posted
    July 8, 2015
    Terminated
    December 22, 2015
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.

    Reason

    The thread location on one of the thread holes is offset from the axis of the predrill hole. The threads are too deep on one side and too shallow on the other. The locking screw may back out of the plate if it does not achieve proper purchase. This may require a revision surgery to replace or remove the screw and/or plate. The threads, not uniformly loaded, may shear off, causing metal slivers.

    Action

    On June 4, 2015 an URGENT MEDICAL DEVICE REMOVAL letter was sent to all consignees. This action requires the immediate location and discontinued use of the product and its return to Biomet. The following actions are REQUIRED: Immediately locate and remove the identified device(s) listed below from circulation; Carefully follow the instructions on the enclosed "Response Form"; Email a copy of the Response Form to [email protected] prior to return of product; Use priority carrier for your shipment; and If you have further distributed this product, you MUST notify hospital personnel of this action via the enclosed "Dear Risk/Recall Manager" notice. This letter MUST be given to hospital personnel responsible for receiving recall notices. However, you are charged with the location and return of these products. Please confirm receipt of this notice by sending back the response form within three (3) business days. Thank you in advance for your assistance and prompt attention. On behalf of Biomet, I apologize for any inconvenience this may cause. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

    Distribution

    Distributed in the states of TX, MD, PA, NJ, NC, MA, AZ, GA, FL, and AR. and the countries of Costa Rica CP and The Netherlands.

    Quantity

    75 units