DePuy Synthes has issued a Class I recall for a bone-cutting power tool battery adaptor because it can explode and cause severe injury or death.
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September 28, 2016 — DePuy Synthes recalled 451 Adaptor and Light Adaptors for its Battery Drive (SBD) and Small Battery Drive (SBD II) surgical power tool system, which includes attachments for drilling or cutting bone in orthopedic surgery. They are only used in hospitals and other healthcare facilities.
What is the problem?
DePuy said the adaptors can potentially produce extreme internal pressure, which may cause the device to explode. This could result in serious adverse health consequences, including death. DePuy notified its customers about the problem in January 2016.
What is the Risk?
The explosion could potentially injure a surgeon using the adaptor, patients undergoing surgery, and/or bystanders and staff in the operating room.
What products were recalled?
The recall includes the SBD and SBD II Adaptor and Light Adaptor with serial numbers 05.001.024 and 05.001.108. They were manufactured from October 6, 2005 to April 5, 2016 and distributed until June 2016.
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