BEUDAMED
    FDA Recall Terminated

    LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.

    Recall: Z-1446-2015 · Initiated March 18, 2015

    Recall

    Recall Number
    Z-1446-2015
    Event Number
    70837
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LXT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 18, 2015
    Posted
    April 14, 2015
    Terminated
    December 11, 2015
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.

    Reason

    A Biomet investigation found that the Low Profile Non-Locking Screw 2.7mmx22mm screw (Part Number: 131227222 Lot: RM105E) was anodized green and should have been anodized gold per the print.

    Action

    On 3/18/2015, Biomet issued an URGENT MEDICAL DEVICE RECALL NOTICE to affected distributors and one medical facility. Notification included the reason for recall, description of affected product, statement of no expected patient health risk, and actions required of the addressee. Questions related to the recall notification should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

    Distribution

    Nationwide Distribution-including the states of CA, IA, NY, FL, PA, UT, NC, SC, KY, CO, MA, GA, WA, TX, OK, and IL.

    Quantity

    45