A total of approximately 950 patient-specific instrumentation sets are affected by this recall. The patient-specific instruments were manufactured and distributed from the Company's new manufacturing facility between July 18, 2015 and August 28, 2015. ConforMIS is seeking the return of the approximately 300 knee replacement product systems, which include the patient-specific instrumentation sets.
Based on an initial assessment, ConforMIS believes that the recalled instrumentation held excess water before undergoing the commonly used ethylene oxide sterilization process and, as a result, may contain small amounts of ethylene glycol residue. Ethylene glycol residue may form when ethylene oxide comes into contact with water.