BEUDAMED
    FDA Recall Terminated

    HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Screws for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

    Recall: Z-0282-2009 · Initiated July 11, 2008

    Recall

    Recall Number
    Z-0282-2009
    Event Number
    50113
    Firm
    Biomet Microfixation, Inc.
    FEI Number
    1032347
    Product Code
    JEY
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    July 11, 2008
    Posted
    November 4, 2008
    Terminated
    September 11, 2009
    Address
    1520 Tradeport Dr, Jacksonville, FL, 32218-2480

    Description

    HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Screws for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

    Reason

    The packaging for the 91-2416, 2.4X16MM HT X-DRIVE SCREW, Lot 493200 actually contained the 99-6577, 2.0X7MM FOSSA X-DRIVE SCREW.

    Action

    An "Urgent Medical Device Recall Notice" was sent to customers on 07/11/2008 by certified letter. The letter described the problem, the risk and asked that customers discontinue use of the product and return them to Biomet. Also, customers were provided with a Inventory Reconciliation sheet and asked to fax it back to Biomet. Please contact Biomet Microfixation at 1-800-874-771 or 904-741-4400, ext. 448 for assistance.

    Distribution

    Nationwide and Canada

    Quantity

    10