BEUDAMED
    FDA Recall Terminated

    12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.

    Recall: Z-2107-2017 · Initiated December 14, 2016

    Recall

    Recall Number
    Z-2107-2017
    Event Number
    76298
    Firm
    MEDLINE INDUSTRIES INC
    FEI Number
    1417592
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 14, 2016
    Terminated
    July 9, 2019
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.

    Reason

    Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.

    Action

    Medline Industries sent an Immediate Action Required letter dated December 14, 2016, to all affected customers with response forms via US mail, notifying them of the recall. Customers were instructed to quarantine affected product and return it to the firm. The product will be repackaged and sterilized. Customers with questions were instructed to call 866-359-1704. For questions regarding this recall call 847-643-3245.

    Distribution

    Nationwide Distribution

    Quantity

    300 individual packs