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FDA announces class I recall for DePuy Synthes power tool system battery adaptors
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The FDA announced a class I recall for the adaptor and light adaptor for DePuy Synthes’ Small Battery Drive and the Small Battery Drive II due to the potential for the adaptors to produce extreme internal pressure, which may cause the device to explode and cause serious adverse health consequences, including death.
According to a release from the FDA, customers of the Small Battery Drive and Small Battery Drive II adaptor and light adaptor should identify and quarantine the device and contact DePuy Synthes Customer Support to obtain a return materials authorization number. Consumers should also complete and return the verification section of the device recall letter to The Anspach Effort Inc., and send a copy of the verification section to DePuy Synthes Customers Quality Department. According to the FDA, the recall notice should be kept visibly posted for awareness. Those who may be affected by this device include surgeons and other health care providers who use the adaptor and light adaptor Small Battery Drive and Small Battery Drive II with their DePuy Synthes power tool systems, patients undergoing surgeries involving these tool systems and adaptors, and bystanders or other staff in the OR when these products are used.
Reference:
www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm522949.htm