DePuy Synthes Craniomaxillofacial Distraction System Recall is Class I

The U.S. FDA has issued its highest classification of recall notice on the DePuy Synthes Craniomaxillofacial (CMF) Distraction System (AB Distractor Bodies and BC Distractor Bodies).

Background

Also called an External Mandibular Fixator And/Or Distractor and a Bone Plate, the DePuy Synthes Craniomaxillofacial (CMF) Distraction System is an implant used to lengthen and/or stabilize the lower jawbone (mandibular body) and the side of the lower jaw (ramus). This device is used in pediatric and adult patients to correct birth (congenital) or post-traumatic defects of the jaw by gradually lengthening the bone (distraction).

Certain lots of the Craniomaxillofacial Distraction System are being recalled because the device may reverse direction and lose the desired distraction distance after surgery. This is clearly not desirable and presents high risk of injury or death, especially to infants in whom failure could provoke sudden obstruction of the trachea can occur with potential for respiratory arrest, and resultant death.

Children or adults with the ability to maintain an open airway are at less risk for serious injury because failure of the device would not result in tracheal obstruction and could be medically reversible. In all patient populations however, failure of the device may result in the need for surgical intervention to replace the failed device.

There have been 15 reports of injury associated with the use of this device.

The specific details of affected products are that they carry manufacturing dates of between April 20, 2009 and April 15, 2011, and were distributed between November 3, 2009 and April 14, 2014

Customers have been advised to review their inventory and remove affected lots from stock, returning them to DePuy Synthes for replacement.

DePuy’s original recall notice, issued in April of this year, can be found here and includes specific batch details.

Source: FDA

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