The federal watchdog labeled the recall as a Class I, the most serious type of recall issued, indicating “a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The company said they are 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.” Such a failure could cause serious adverse health consequences, including death.
The recall affects a total of 451 units, according to the release. Serial numbers 05.001.024 and 05.001.108 were identified in the recall, with manufacturing dates between Oct. 6, 2005 and April 5, 2016 and distribution dates between Jan. 2006 and June 2016.
DePuy Synthes said it sent a letter to affected customers in January, instructing them to identify and quarantine affected devices and contact the company to continue the process of returning and replacing the units.