STANMORE KNEE IMPLANTS BANNED IN U.S. (Orthopedics This Week)
Read the Warning Letter, click here.
Extendable femoral and total knee replacement devices made by UK’s Stanmore Implants Worldwide Ltd have been refused entry into the U.S. by the FDA.
“Entry Refused”
The FDA is throwing the quality system rulebook at Stanmore and notified the company back in November 2014 in a Warning Letter that entry into the U.S. of their devices will be refused, under its authority for “detention without physical examination.” The agency also notified other U.S. federal agencies about the warning so they can take the information into account when considering the award of contracts. In addition, the agency will not consider premarket applications from the company until the quality system deviations are corrected.
Quality System Violations
During an inspection at the company in July 2014, an FDA investigator found a long list of quality system violations. Specifically, “the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found a...
