A warning letter dated Nov. 20 by the U.S. Food and Drug Administration cites Contract Medical Manufacturing (CMM) for shipping finished devices without making sure they met sterilization criteria and failed to investigate complaints of patients who developed infections.
The Oxford, Conn.-based company, which produces custom cranial implants for orthopedic device maker Stryker, stopped shipment of the devices during the FDA’s inspection of its Oxford plant last September, the letter says.
Stryker recalled the implants in late October because their sterility could not be verified. The devices are designed to correct trauma or defects in the upper and lower jaw, face and cranium. CMM said still no shipments are being made.