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.
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