DePuy's Craniomaxillofacial Distraction System lengthens and stabilizes bone in the lower jaw in patients with birth or post-traumatic defects, but the company uncovered a potentially deadly design flaw that could block airways in infants, MassDevice reports. Federal regulators assigned its highest-risk warning to the issue after DePuy reported 15 injuries associated with the device. The agency reserves its Class I label for situations where there is "reasonable probability" that the product will cause injury or death.
DePuy first notified patients about the problem in April when it issued an urgent notice to providers to remove its jaw-stabilizing system from inventory. The company recalled all lots of the device manufactured from April 20, 2009, to April 15, 2011, but the implants were distributed up until April 14, 2014, according to the MassDevice story.
The regulatory backlash comes on the heels of more bad news for J&J, as the company announced in July that it would pull its controversial power morcellator devices from the global market. The med tech giant had already suspended sales of its morcellator products in April following an FDA advisory warning that discouraged physicians from using the tools in surgical procedures.
DePuy also faces its fair share of problems as it deals with the fallout of its defective all-metal hip implants. Last November, J&J/DePuy agreed to fork over $2.5 billion to settle thousands of lawsuits alleging injuries caused by the devices, but the company is still defending itself against the remaining claims.
Still, J&J's device and diagnostic unit continues to churn out promising numbers and strive toward innovation. DePuy posted $28.5 billion in sales for 2013--about 40% of the company's overall revenue--and inked a deal earlier this year with 3-D printing company Tissue Regeneration Systems to develop patient-specific, resorbable implants for use in trauma and orthopedic oncology.
- read the MassDevice story
- here's the FDA's note
- and DePuy Synthes' letter to customers (PDF)