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 t...
The Orthopedics Industry 
