Events

Recall of Craniomaxillofacial (CMF) Distraction System (modular family of internal distraction devices to lengthen the mandibular body and ramus) BC Distractor Body, end activated, with Universal Joint for CMF Distractor:Distraction length 15 mm

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Synthes Australia Pty Ltd.

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
    RC-2014-RN-00478-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-04-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00478-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The bc distractor bodies used in the craniomaxillofacial distraction system may reverse post-operatively. reversing occurs when the distractor screw turns in the opposite direction and causes the assembly to lose distraction distance. 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. additionally, there is the potential for those patients with an already compromised mandible anatomy to be at higher risk of partial or complete airway obstruction (critical obstructed airway / choking).
  • Action
    Synthes Australia is requesting hospitals to immediately isolate all affected units. All units are to be returned to Synthes Australia for replacement or credit. Treating physicians are also being notified of the potential for reversing and the associated risks to patient health. To mitigate the risk of a distractor reversal, patients should be closely followed until a clinical and/or imaging examination confirms the desired outcome. The type of post-operative care and supportive treatment should be determined by the surgical team based on a variety of factors that includes, but is not limited to, the severity of the abnormality, the age of the patient, caregiver environment, ability to protect the airway, maintain nutritional status, and other co-morbidities. For more details, please see http://www.tga.gov.au/safety/alerts-device-craniomaxillofacial-distraction-system-140429.htm . This action has been closed-out on 18/02/2016.

Device

Craniomaxillofacial (CMF) Distraction System (modular family of internal distraction devices to l...
  • Model / Serial
    Craniomaxillofacial (CMF) Distraction System (modular family of internal distraction devices to lengthen the mandibular body and ramus)BC Distractor Body, end activated, with Universal Joint for CMF Distractor:Distraction length 15 mmPart No: 04.315.063Lot No: 6883301Distraction length 30 mm Part No: 04.315.066 Lot No: 7082908Distraction length 40 mm Part No: 04.315.068 Lot No: 7266969; IS10386ARTG No: 183673
  • Product Classification
    Dental Devices
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd