Class I Recall Issued by FDA for DePuy Synthes Craniomaxillofacial Distraction System
On August 28, 2014, the FDA notified healthcare professionals of a Class I Recall of the DePuy Synthes Craniomaxillofacial (CMF) Distraction System (AB Distractor Bodies and BC Distractor Bodies). The FDA explained that “DePuy Synthes is recalling certain lots of the Craniomaxillofacial Distraction System because the device may reverse direction and lose the desired distraction distance after surgery.” At the time of the press release, there were 15 reported injuries associated with the use of the device.
Prior to this time, DePuy Synthes had sent an Urgent Notice to healthcare providers on April 16, 2014 identifying the problem with the system and instructing facilities to remove affected lots from their stock.
The DePuy Synthes CMF Distraction System is used primarily in pediatric and adult patient surgeries to correct congenital or post-traumatic jaw defects by gradually lengthening the jaw bone. The FDA included the Recall Notice, which includes a complete listing of affected products with part/lot numbers.
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