Recent ConforMIS Recall Leads to Lawsuit

At the end of August, officials with Bedford, Mass.-based ConforMIS Inc. reported a voluntary recall of specific serial numbers of patient-specific instrumentation for the company’s iUni, iDuo, iTotal CR and iTotal PS knee replacement product systems.

The recall was initiated as the result of three recent complaints of moisture on the patient-specific instrumentation. In all three cases, the knee replacement procedures were completed without apparent incident, company officials said that they do not believe that the customized knee implants used in these procedures were affected.

“While the number of complaints the company has received is small, and the company has not received any reports of adverse events related to these complaints to date, the company initiated this recall voluntarily and is working to resolve the complaints quickly,” according to a release from the company.

Based on an initial assessment, ConforMIS execs believe 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. ConforMIS temporarily suspended the use of the ethylene oxide sterilization process, and officials said the company was “working expeditiously” to investigate the root cause of the excess moisture and evaluate potential corrective and preventative actions.

A total of approximately 950 patient-specific instrumentation sets were affected by the recall, of which approximately 650 sets were used in knee-implant procedures and approximately 300 sets were shipped but not yet used in scheduled surgeries. The patient-specific instruments were manufactured and distributed from the company’s new manufacturing facility between July 18 and Aug. 28.

ConforMIS says it notified the affected healthcare facilities of this recall and arranged for replacement of the recalled products.

The company reported that manufacturing would be “substantially reduced” this month and possibly October as it completes its investigation and executes a plan of resolution.

ConforMIS officials said the company uses a validated, alternative sterilization process that it already uses in the production of other implants and instruments and plans to increase its reliance on this alternative process until it has completed its investigation and taken all necessary corrective action. This alternative sterilization process has significantly limited capacity as compared to the ethylene oxide sterilization process.

Now, in the last week, the company faces a lawsuit as a result of the product difficulties and recall. The lawsuit was filed in the United States District Court, District of Massachusetts, by The Briscoe Law Firm PLLC of Dallas, Texas, and securities litigation firm Powers Taylor LLP, also of Dallas. The suit claims that ConforMIS violated certain provisions of the Securities Exchange Act of 1934, failed to disclose that its manufacturing processes were flawed and that a number of the knee replacement devices were defective as a result.