BEUDAMED
    FDA Recall Terminated

    Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

    Recall: Z-1327-2016 · Initiated February 23, 2016

    Recall

    Recall Number
    Z-1327-2016
    Event Number
    73561
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    DZL
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 23, 2016
    Posted
    April 5, 2016
    Terminated
    September 8, 2016
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

    Reason

    Out of specification at the thread. The thread height of these screws is under-sized. The cross section of the affected area is less than that of conforming screws such that the thread height of the screws is undersized.

    Action

    DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated February 23, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were notified by mail of a potential patient impact. They were instructed to review existing inventories and call DePuy Synthes at 1800-479-6329 to obtain a Return Authorization (RA) Number and replacement order. After completing the verification section on page 4 of the letter, they were advised to return the verification section (page 3) with the product to Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. A copy of the completed verification section is to sent to DePuy Synthes by: Fax 877-931-0643 or scan/email [email protected].

    Distribution

    Worldwide Distribution - US Nationwide in the states of MA, VA, TN, GA, WA, IA, NJ, TN, PA, NY, CO, CT, VT, and the countries of Canada and Switzerland.

    Quantity

    150 units distributed in US, 1439 units distributed OUS (foreign)