The FDA slapped Stanmore Implants with an import ban until the British orthopedic implant maker deals with problems flagged in a warning letter from the federal safety watchdog.
That means Stanmore products, including implantable extendable femoral and total knee replacement devices, are subject to "detention without physical examination," the FDA said.
Stanmore also faces a delay of premarket approval for any Class III devices connected to the regulatory quality citations, according to the warning letter.
The Elstree, U.K.-based company did not respond to an email from MassDevice.com.
The Nov. 26, 204 warning letter, which was recently released by the FDA, is based violations found during an inspection of Stanmore’s U.K. manufacturing facility July 28 to July 31, 2014. The company does not have proper procedures to address and prevent manufacturing problems and doesn’t adequately document corrections made to address future quality problems, according to the letter.
Stanmore also failed to ensure a consistent response to complaints and doesn’t document oral complaints, the FDA said. The company also failed to start and maintain processes for quality audits to ensure compliance and to report a potentially deadly device malfunction within 30 days.
Stanmore received complaints that a long-term implant malfunctioned but failed to establish that the issue would not cause serious injury or death, according to the agency.
