ConforMIS Inc. has announced its completion of an investigation about excess moisture and ethylene glycol residue on several of the company’s total knee replacement offerings, in which an independent testing laboratory found no significant health risk to patients from ethylene glycol residue on the affected instrumentation and found no residue on tested implants.
“Based on the results of the investigation, ConforMIS believes that no monitoring of patients is necessary,” according to a ConforMIS press release.
The research tested specific serial numbers on patient-specific instrumentation for the company’s iUni, iDuo, iTotal CR and iTotal PS knee replacement products.
The company added, “The results of ConforMIS’ investigation suggest that the affected instrumentation underwent the commonly used ethylene oxide sterilization process in the presence of excess water and, as a result, contained small amounts of ethylene glycol residue. ConforMIS is in the process of completing final testing and implementing corrective actions, and expects to resume full production in October.”