Recalled Devices Cause Serious Injuries or Death – Findings. Medical device maker DePuy Synthes has recalled power sources for surgical power tool systems because these components could explode.
The Food and Drug Administration (FDA) has identified this as a Depuy Synthes Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. An explosion could injure or kill not only the surgeon and the patient but also others present in the operating room.
The recalled products are the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II (serial numbers 05.001.024 and 05.001.108). The devices were manufactured from October 6, 2005 to April 5, 2016 and were distributed nationwide from January 2006 through June 2016.
DePuy Synthes, a division of Johnson & Johnson, is recalling the Adaptor and Light Adaptor for their SBD and SBD II due to a potential for the adaptors to produce extreme internal pressure, which may cause the device to explode.
The Adaptor and Light Adaptor
The Adaptor and Light Adaptor are power sources for the DePuy Synthes Small Battery Drive (SBD) and the Small Battery Drive II (SBD II) surgical power tool systems. The SBD and SBD II power the Synthes Power Tool system, used for drilling or cutting bone during orthopedic surgery.
DePuy Synthes sent an Urgent Notice-Medical Device Recall letter to all affected customers on June 24, 2016. In the letter, the company asked customers to identify and quarantine any of the recalled devices in their facility. Health care facilities should contact DePuy Synthes Customer Support at 1-800-327-6887, to obtain the necessary return authorization information. The letter asks health care facilities to keep the recall notice the recall notice “visibly posted” for staff awareness.
Health care professionals and consumers may contact Customer Quality at-1-800-327-6687 #3, with any questions related to this recall.