J&J’s DePuy Synthes is recalling two battery drive adaptors used to power surgical tools--including attachments for the drilling or cutting of bone in orthopedic surgery--because they may explode.
This week, the FDA slapped the recall with a Class I designation, the most serious kind. DePuy initiated the recall in June, sending out a letter asking customers to quarantine the devices, adaptors for the Small Battery Drive (SBD) and the SBD II, and to complete steps to return them to the company.
The SBD II is a battery-driven device in DePuy’s Power Tool stable. It has a number of attachments for use in orthopedic surgery, including spine surgery, foot and ankle surgery, hand and wrist surgery and general traumatology. The adaptors are being recalled because they have the potential to produce severe internal pressure that may cause them to explode, the FDA said.
This is the latest in a string of quality-control problems for J&J. Back in March 2015, its Biosense Webster unit recalled an electrophysiology cardiac catheter because of difficulties retracting it. And that same month, DePuy recalled 1,500 titanium elastic nail inserters used in surgeries to mend long bone fractures. The device was recalled because it was susceptible to mechanical failure during surgery.
The previous year, DePuy recalled its jaw-stabilizing Craniomaxillofacial Distraction System, a move that the FDA designated as Class I. The device is designed to lengthen and stabilize the lower jaw in patients with birth or post-traumatic defects, but was found to potentially block airways in infants.