The FDA issued a Class I designation for a recall of Johnson & Johnson DePuy Synthes Small Battery Drive and the Small Battery Drive II surgical power tool systems over faulty adapters that produce extreme internal pressure leading to explosions, Qmed reports.
Here's what you need to know.
1. The recall is for 451 adaptor and light adaptor power sources for the Small Battery Drive and the Small Battery Drive II. The recall is used for AC power rather than those powered by battery power. There are several complaints related to those powered with batteries, but those are "unrelated," DePuy Synthes spokesperson Mindy Tinsley said.
2. All the units were distributed in the U.S. and were made between Oct. 6, 2005 and April 5, 2016. They were distributed between January 2006 and June 2016.
3. The tools are only used in hospital and healthcare settings, and generally for orthopedic surgery.
4. DePuy Syntheses sent a recall letter to all affected customers.
5. There were several reports concerning the adopter, but only two reported explosions; one in Germany and one during a veterinary procedure. No one was injured.
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