BEUDAMED
    FDA Enforcement Class II Terminated

    3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.

    Recall: Z-1941-2013 · Reported August 21, 2013

    Enforcement

    Recall Number
    Z-1941-2013
    Event ID
    65828
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    OrthoPediatrics Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 21, 2013
    Initiation Date
    July 24, 2013
    Classification Date
    August 9, 2013
    Termination Date
    August 26, 2013
    Address
    2850 Frontier Dr, Warsaw, IN, 46582-7001, United States

    Description

    3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.

    Reason

    OrthoPediatrics has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Only drill bits that are in their original packaging are being recalled. The description on the package of this drill bit has a wrong size in the description (3.2mm). The recall affects only packaged devices still in original packaging due to misbranding of the product. The drill bit itself has

    Code Info

    LOT 91300335 - Catalogue Number 01-1050-0002

    Distribution

    Nationwide distribution, including the states of MO, MI, WA, FL, NY, TN, CO, AZ, VA, TX, CA, MN, LA, NC, and UT.

    Quantity

    68