BEUDAMED
    FDA Recall Terminated

    Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone

    Recall: Z-0709-2019 · Initiated November 20, 2018

    Recall

    Recall Number
    Z-0709-2019
    Event Number
    81704
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LXT
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    November 20, 2018
    Terminated
    April 14, 2020
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone

    Reason

    One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws

    Action

    Zimmer Biomet issued Urgent Medical Device Recall letter on 11/20/18 advising of the problem, heath risk and action to be taken- Quarantine and return product. Complete Attachment 1 Certificate of Acknowledgement. Contact customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.

    Distribution

    Country of Japan

    Quantity

    50 pieces