The FDA sent a warning letter to Conformis, a Billerica, Mass.-based devicemaker specializing in knee implants, citing sterilization issues with the company's knee replacement systems, according to MedTech Dive.
The letter, dated Dec. 10, said the FDA had previously alerted Conformis to the sterilization issues, but Conformis had failed to establish procedures to correct and prevent the issues from happening again.
The issues relate to Conformis' vaporized hydrogen peroxide sterilizers, which the FDA said have failed to properly sterilize products in several instances.
Conformis said in a U.S. Securities and Exchange Commission filing that it uses the sterilizers as a secondary sterilization method in limited circumstances and on a small number of its products.
Conformis also said in the filing that the FDA did not say the sterility of Conformis' products were compromised. The company said it is working to address the issues and it doesn't expect them to cause an interruption in manufacturing, distribution or its new product launch schedule.
Conformis said it has been planning to replace the sterilizers and has submitted a request for approval from the FDA for a new sterilization unit, but the FDA said the request from Conformis does not resolve the agency's immediate concern of assuring the sterility of its devices.
The FDA gave Conformis 15 days to respond, telling how it plans to prevent the recurrence of the violations and to provide evidence its sterilizers can pass validation under routine operating conditions, according to MedTech Dive.
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