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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00478-1
Product Name/Description	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 Part No: 04.315.063 Lot No: 6883301 Distraction length 30 mm Part No: 04.315.066 Lot No: 7082908 Distraction length 40 mm Part No: 04.315.068 Lot No: 7266969; IS10386 ARTG No: 183673
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	24/04/2014
Responsible Entity	Synthes Australia Pty Ltd
Reason/Issue	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).
Recall Action	Hazard Alert
Recall Action Instructions	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.
Contact Information	02 9855 4620 - Synthes Australia Pty Ltd