BEUDAMED
    FDA Recall Terminated

    Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures

    Recall: Z-0407-2014 · Initiated July 30, 2013

    Recall

    Recall Number
    Z-0407-2014
    Event Number
    66419
    Firm
    Synthes USA HQ, Inc.
    FEI Number
    3005180112
    Product Code
    JDS
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    July 30, 2013
    Posted
    November 27, 2013
    Terminated
    September 10, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures

    Reason

    The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.

    Action

    Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section and return to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If customers do not have any affected product they should still complete Verification Form and return to Synthes by fax to 1-888-731-7954 or Scan/email: [email protected]. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-519-5000.

    Distribution

    Worldwide Distribution - USA (nationwide) including SC, IA, NC, TX, KY, VA, AL, PA, and Internationally to Canada.

    Quantity

    14