In the last few years, ConforMIS, Inc. has recalled the iTotal and iUni knee replacements to address safety problems with a low risk of causing injury.  Now the company faces a huge drop in production and sale profits with its most recent voluntary recall of its customized knee replacements, according to MassDevice.

Implant Recall Information

According to the U.S. Food and Drug Administration (FDA), the recall affects the company’s iUni, iDuo, iTotal CR and iTotal PS devices (approx. 950 instrumentation sets). The instruments were made at a new plant in nearby Wilmington, Mass., between July 18 and August 28, the company said.

About 300 devices have shipped for scheduled procedures but have not been used; ConforMIS is seeking the return of said devices.

The company expects a significant decline in sales from $72-74 million to a whopping $64-66 million. Production will also take a plunge during the next months of September and October 2015 while the company investigates and corrects the problem.

The company has received 3 complaints of moisture on the patient-specific instrumentation used with the implants, according to ConforMIS; however, all 3 implant procedures were successfully completed.

ConforMIS Product Recall History

• In July 2009, ConforMIS recalled 10 of the iUni sets due to concern about microscopic cracks that could potentially increase a patient’s risk of premature revision surgery. The Class II recall did not cite any patient injuries.
• ConforMIS recalled 1,427 units of the iTotal CR knee replacement and added prominent updates to the surgical technique guide. The Class II recall was issued in August 2012.
• Between January 2011 and March 2014, the FDA received about 30 reports of spacer dislodgment or tibial tray loosening associated with the ConforMIS iTotal G2 Knee Replacement System. This caused its users a number of complications including immobility, bone damage, and the need for revision surgery.
• The ConforMIS iTotal G2 was approved in January 2011 via the FDA’s 510(k) loophole, which requires little safety data and only some information concerning the products’ efficacy.

ConforMIS is undergoing the process of alerting the affected healthcare facilities of this recall and is preparing for the immediate replacement of the recalled products.  ConforMIS will soon be issuing a Customer Notification letter to each affected healthcare facility specifying steps for the return of affected products.