24 Jun 2016
Date Recall Initiated: June 24, 2016
Possible Explosion Risk
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product:
- Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II
- Serial Numbers: 05.001.024 and 05.001.108
- Manufacturing Dates: October 6, 2005 to April 5, 2016
- Distribution Dates: January 2006 to June 2016
- Devices Recalled in the U.S.: 451 units distributed nationwide
Reason for Recall
DePuy Synthes 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.
Who May be Affected
- Surgeons and other health care providers using the Adaptor and Light Adaptor SBD and SBD II with their DePuy Synthes Power Tool systems.
- Patients undergoing surgeries involving these tool systems and adaptors.
- Bystanders or other staff who are in an operating room where these tool systems and adaptors are used.
What to Do
On June 24, 2016, DePuy Synthes sent an "Urgent Notice-Medical Device Recall” letter to all affected customers. The letter asked customers to:- Identify and quarantine the device.
- Contact your local DePuy Synthes Customer Support to obtain a Return Materials Authorization Number if it is relevant.
- Complete and return the Verification Section of the device recall letter to your local distributor.
- Keep the recall notice visibly posted in your facility for awareness.
Source: FDA
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