J&J Hit with Serious Recall over Jawbone Lengthener

Chris Newmarker

August 28, 2014

1 Min Read
J&J Hit with Serious Recall over Jawbone Lengthener

Johnson & Johnson is facing another serious recall, this time involving a jawbone lengthening bone plate produced by its DePuy Synthes subsidiary.The FDA on Thursday announced a Class I designation for J&J's voluntary recall of the DePuy Synthes Craniomaxillofacial Distraction System.FDA officials think certain lots of the system could cause serious injury or death because the devices may reverse direction and lose the desired distraction distance after surgery. There have already been 15 reports of injuries, according to the FDA. Infants are at the highest risk of injury or death in such a situation because sudden obstruction of the trachea could occur, the FDA said.

This is Johnson & Johnson's 12th Class I-level recall since the start of 2012. It's the highest number among medical device companies.The Craniomaxillofacial Distraction System is meant to lengthen and/or stabilize the lower jawbone (mandibular body) and the side of the lower jaw (ramus) in children or adults with birth defects or injuries to the jaw.A full list of affect part and lot numbers is included with the DePuy Synthes recall notice.

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.

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