BEUDAMED
    FDA Recall Terminated

    DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)

    Recall: Z-2148-2014 · Initiated April 16, 2014

    Recall

    Recall Number
    Z-2148-2014
    Event Number
    68071
    Firm
    Synthes, Inc.
    FEI Number
    3005180112
    Product Code
    MQN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 16, 2014
    Posted
    August 20, 2014
    Terminated
    September 9, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)

    Reason

    DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) because they may reverse post-operatively.

    Action

    The firm, DePuy Synthes, sent "Urgent Notice: Medical Device Recall" letters dated April 16, 2014 to affected customers. The letter identified the affected product, reason for recall, potential patient impact, mitigation steps for patients with distractors currently implanted and actions to be taken. Customers were instructed to review inventory, immediately remove the affected lots from stock, complete verification section of the letter and return the affected product. For questions call 610-719-5450 or contact your DePuy Synthes Sales consultant.

    Distribution

    US Nationwide Distribution

    Quantity

    1499