A new Class I-level recall involves 451 adaptor and light adaptor power sources for the DePuy Synthes Small Battery Drive and the Small Battery Drive II surgical power tool systems.

Chris Newmarker

FDA on Wednesday issued a Class I designation for a recall at Johnson & Johnson's DePuy Synthes business involving surgical tool power source adapters that might cause the devices to produce extreme internal pressure and explode. 

The recall includes 451 units of the adaptor and light adaptor power sources for the DePuy Synthes Small Battery Drive and the Small Battery Drive II surgical power tool systems. All 451 units were distributed in the U.S. They were made between October 6, 2005 and April 5, 2016, and distributed between January 2006 and June 2016. More information is available on FDA's website. 

The surgical tool systems, which include attachments for drilling or cutting bone during orthopedic surgery, are only used in hospital and healthcare settings. 

DePuy Synthes sent an "Urgent Notice-Medical Device Recall" letter to all affected customers in January, according to FDA. 

J&J media relations could not be immedately reached for comment. 

A search for "Small Battery Drive" on FDA's MAUDE database turns up hundreds of reports related to problems around the DePuy Synthes devices in 2016 alone. But only two report explosions--one out of Germany and another that took place during a veterinary procedure. No injuries or deaths were reported in either case. 

"As of today, the company has received one report of an adaptor bursting with no injuries occurring. The company has requested that hospitals immediately stop using the recalled adaptors and return them to the company as soon as possible," DePuy Synthes spokesperson Mindy Tinsley told Qmed via email.

"It's important to note that the adapter that was recalled was used for AC power rather than battery power and the complaints related to batteries are unrelated to this recall," Tinsley added.

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

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[Image courtesy of FDA]