FDA Warns Knee and Hip Replacement Devicemaker Over Sterilization
The FDA hit Conformis with a warning letter over failures of a sterilization method for knee implants at its Wilmington, Mass., facility.
An agency inspection found failures relating to vaporized hydrogen peroxide sterilizers that the company used as an alternative sterilization method for some products.
The devicemaker lacked evidence that the sterilization process “ensures products consistently meet the established sterility assurance level under routine operating conditions,” the agency said.
In a filing to the SEC, Conformis claimed that the sterility of its products was not jeopardized, and that the warning letter would not affect its manufacturing operations.