FDA Places Most-Serious Class I Label on J&J's DePuy Synthes Recall of Jaw-Stabilizing DeviceDec 9, 2014
The U.S. Food and Drug Administration (FDA) has placed its most-serious Class I label on Johnson & Johnson’s DePuy Synthes recall of its jaw-stabilizing device. A Class I designation is the FDA’s most serious recall status; it means that use of the recalled device has “reasonable probability” of causing serious injury or death.
DePuy recalled the DePuy Synthes Craniomaxillofacial (CMF) Distraction System (AB Distractor Bodies and BC Distractor Bodies) in April. The product is also called an External Mandibular Fixator and/or Distractor and a Bone Plate, the recall notice states. The device is used to stabilize bone in the lower jaw in patients with birth defects or post-traumatic defects.
The recall was issued because “the device may reverse direction and lose the desired distraction distance after surgery” the notice read. This could lead to obstruction of the airway in infants, which could “lead to respiratory arrest, and result in death.” This defect has been linked to 15 injuries so far. The recalled lots were manufactured from April 20, 2009 to April 15, 2011. MassDevice reports, however, the devices were distributed up until April 14, 2014.
J&J has been faced with a number of safety issues over its medical devices. In July, the company pulled its power morcellator device from the market. The FDA discouraged the use of morcellators in April, warning that it may spread a hidden uterine cancer. Sales of the devices were suspended thereafter.
Additionally, there are still a number of lawsuits over metal-on-metal hip implants manufactured by J&J's DePuy unit. Last year, the company agreed to pay $2.5 billion last year to settle thousands of personal injury lawsuits allegedly caused by the devices but there are still a number of cases remaining.