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DePuy Synthes CMF Distraction System Recalled Over Potentially Fatal Defect

Brian Finehout-Henry2 years ago

On August 28th, 2014 the U.S. Food and Drug Administration (FDA) issued a class 1 recall for the DePuy Synthes Craniomaxillofacial, CMF, Distraction System over concerns about the device reversing.

The DePuy Synthes CMF Distraction System is manufactured by DePuy Synthes, a subsidiary of Johnson and Johnson. The CMF Distraction System is used to correct birth defects and traumatic injuries, which affect the bones of the face. It works to stabilize and elongate the mandible.

Class 1 Recall for DePuy Synthes CMF Distraction System

The FDA issued a class 1 recall, which is the most serious recall, used only when the use of the drug or device can cause severe injury and/or death.

Fierce MedicalDevices reports that all lots of the Craniomaxillofacial Distraction System manufactured between April 20th, 2009 and April 15, 2011 and distributed up till April 2014 are being recalled.

The FDA is warning that the DePuy Synthes CMF Distraction System can fail, leading to an obstructed airway, respiratory arrest and potentially death, according to ReutersFox News is reporting that infants are at the highest risk of airway collapse with device failure and surgery could be needed to remove and replace the failed device.

DePuy Synthes Craniomaxillofacial Distraction System Recall Information

The FDA initiated the recall after receiving 15 reports of injuries associated with CMF Distraction System failure, according to BioSpace.

The FDA reports the device can also be called an External Mandibular Fixator and/or a Distractor and Bone Plate. DePuy Synthes sent out warning letters in April stating that its AC Distractor Bodies and BC Distractor Bodies could reverse, leading to prolonged treatment, repeat surgeries, and potentially an obstructed airway and choking.

Lots Recalled

The FDA is recalling DePuy Synthes Craniomaxillofacial Distraction Systems with the following product information:

  • Part Numbers: 04.315.003, 04.315.004, 04.315.005, 04.315.006, 04.315.023, 04.315.024, 04.315.025, 04.315.026, 04.315.027, 04.315.028, 04.315.053, 04.315.054, 04.315.055, 04.315.056, 04.315.063, 04.315.064, 04.315.065, 04.315.066, 04.315.067, 04.315.068
  • Lot Numbers: 6245205, 7129328, IS10400, 6246203, 6582199, 6794535, 6814674, 6877737, 6921359, 6981567, 7008430, 7081952, 7129329, 7460419, 7556148, 6246984, 6342006, 6964974, 7129330, 7460420, 6246983, 7389334, 7422735, 7515818, 6245460, 6342005, 6454138, 6495399, 6651393, 6816023, 6898959, 6921360, 7306561, 7515824, 6307904, 6365443, 6410544, 6438375, 6625839, 6651392, 6984928, 7241620, 7351855, 7390470, 7408179, 7458272, 7458273, 7458274, IS10394, 6450702, 6454139, 6553925, 6625840, 6883404, 6921586, 7031344, 7185897, 7389329, 7408181, 7422706, 7422707, 7422708, 7458299, 7515832, IS10385, 6393118, 6393119, 6410545, 6454140, 6512859, 6625841, 6651391, 6984925, 7185895, 7408182, 7422703, 7422704, 7422705, 7515829, 7515830, 6393120, 7408180, 7515833, 7122918, 7389333, 7422700, 7545381, IS10388, 6252759, 7129331, 7155891, 7418771, 7448753, 6245463, 6438376, 6981568, 6983876,7063885, 7129332, 7309797, 7418772, 7418848, 7448754, 6251769, 7081953, 7310030, 7365542, 7418849, 7448752, 7448758, 7556149, 6245458, 6342007, 7129333, 7556150, IS10399, 6245462, 6342003, 6824546, 6824551, 6883290, 6883301, 7082907, 7266972, 7476792, 7476810, 7657623, 6280719, 6342004, 6394297, 6651390, 6737168, 6767617, 6824547, 6824550, 6883304, 6883305, 6961025, 6984927, 7041138, 7056051, 7111867, 7185893, 7266967, 7351857, 7351858, 7351859, 7351861, 7422701, 7545379, 7657820, IS10395, 6651389, 6702172, 6883306, 6883307, 6942444, 6984926, 7111868, 7185892, 7306562, 7306563, 7306564, 7499078, 7515834, 7657629, IS10389, 6651388, 6741835, 6824553, 6883309, 6913921, 6942445, 6961024, 7082908, 7111869, 7122924, 7185888, 7515835, 7657633, 6921585, 6942446, 7185887, 7306565, 7306566, 7408183, 7476791, 7567066,7579433, 7657635, IS10390, IS10391,6275129, 7082905, 7185890, 7266969, 7422697, 7609200, IS10386, IS10387

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