Events

Recall of Device Recall Synthes Craniomaxillofacial (CMF) Distraction System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes USA HQ, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65670
  • Event Risk Class
    Class 2
  • Event Number
    Z-1726-2013
  • Event Initiated Date
    2013-06-12
  • Event Date Posted
    2013-07-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119842
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    External mandibular fixator and/or distractor - Product Code MQN
  • Reason
    The firm initiated a voluntary recall of the bc distractor body which is part of the craniomaxillofacial (cmf) distractor system, due to a mis-alignment issue. there have been instances reported within the impacted lots in which the slot in the barrel of the bc distractor was rotated such that it was not possible to attach the b-type and c-type foot plates.
  • Action
    SYNTHES sent an Urgent Notice: Medical Device Recall letter dated June 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to examine their inventory for affected product, remove it from use, and return it to Synthes. If they have affected product they were instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section at the end of the letter and indicate the number of devices found and note the Return Authorization Number and return to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If customers did not have the affected product they were asked to complete the Verification Section and faxt to 610-251-9005. Customers with questions were instructed to call 610-719-5450 or e-mail FieldAction@synthes.com. For questions regarding this recall call 610-719-5450.

Device

Device Recall Synthes Craniomaxillofacial (CMF) Distraction System
  • Model / Serial
    Part # 04.315.067 with lot #s 6184270 and/or 22612-04.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including PA, CT, DE, and NY.
  • Product Description
    Synthes CMF Distraction System || The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.
  • Manufacturer
    Synthes USA HQ, Inc.

Manufacturer

Synthes USA HQ, Inc.
  • Manufacturer Address
    Synthes USA HQ, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA