Events

Recall of Synthes Craniomaxillofacial (CMF) Distraction System, BC Distraction Bodies

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Synthes GmbH.

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
    16596
  • Event Initiated Date
    2014-05-14
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Synthes New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, Auckland 1060
  • Reason
    The ab and bc distractor bodies used in the craniomaxillofacial distraction system may reverse post-operatively., in the presence of inadequate distraction or reversal of a previously achieved distraction distance, the patient may need to undergo prolonged distraction therapy. in some instances, revision surgery may be needed to replace the device., reversing occurs when the distractor screw is turned in the opposite direction to cause the assembly to lose distraction distance.
  • Action
    Product to be returned to supplier

Device

Synthes Craniomaxillofacial (CMF) Distraction System, BC Distraction Bodies
  • Model / Serial
    Model: Models: 04.315.064 and 04.315.066, Affected: Lots: 6342004, 7351857 and 6651388, 6913921, 718588 respectivly
  • Product Classification
    Dental Devices
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH