DePuy Synthes announced on September 28, 2016, that it 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 use of affected products may cause serious adverse health consequences, including death.
Recalled products include the adaptor and light adaptor for the small battery drive and small battery drive II with serial numbers 05.001.024 and 05.001.108. These were manufactured from October 6, 2005, to April 5, 2016, and distributed from January 2006 to June 2016. The company reports that 451 units were distributed nationwide.
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, which includes attachments for drilling or cutting bone in orthopedic surgery. The adaptors and surgical tool systems are only used in hospitals and other health care facilities.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the FDA Safety Alert
See the Recall
See also Medical Law Perspectives, July 2013 Report: New Hips, New Knees, New Problems: Hip and Knee Replacements