ConforMIS, a manufacturer of 3-D printed knee implants, has announced a voluntary medical device recall for a number of knee replacement systems, following complaints of moisture on the patient-specific instrumentation used with the products. The ConforMIS knee recall impacts more than 900 iUni, iDuo, iTotal CR and iTotal PS knee systems.
According to the company’s August 31st recall notice, it has received three complaints of moisture on the patient-specific instrumentation. In all three cases, knee replacement procedures were completed without apparent incident. ConforMIS does not believe that the customized knee implants used in these procedures were themselves affected, and no adverse event reports have been received by the company.
According to ConforMIS the affected instrumentation may have held excess water before undergoing a sterilization process that utilized ethylene oxide. As such, the instrumentation may contain small amounts of ethylene glycol residue, which forms when ethylene oxide comes into contact with water.
The ConforMIS knee implant recall affects 950 patient-specific instrumentation sets, including 650 that were used in knee implant procedures. The remaining 300 were shipped, but haven’t yet been used in procedures. ConforMIS does not believe that the customized knee implants included with the sets themselves were affected. The company is in the process of notifying the affected healthcare facilities and is arranging for replacement of the recalled product, which were distributed between July 18, 2015 and August 28, 2015.
As a result of the ConforMIS knee implant recall, the company said it expects manufacturing to be substantially reduced in September and possibly October as it completes its investigation and executes a plan of resolution. As such, ConforMIS has revised its 2015 revenue guidance downward. When the recall was announced, ConforMIS stock fell $3.78 per share, or 19%, to close at $16.00 per share on August 31st. At the close of trading on September 4th, the company’ stock was trading at around $14.00 per share.