Endotec Warned for Investigation, Design Validation Failures

Orthopedic devicemaker Endotec has been warned for several GMP violations, including investigation failures for a device part that fell out during surgery.

Although Endotec determined the mating holes of a tibial platform’s pin stop were oversized, causing it to fall out, the company did not find the root cause necessary to implement a corrective or preventive action, according to the Oct. 22 warning letter. The pin stop malfunction has occurred previously, it adds.

A May 18 through 29 inspection of Endotec’s Orlando, Fla., facility revealed another pin stop malfunction during surgery due to improperly reworked tibial platforms that caused the pin hole to be deformed. A root cause was not determined, the letter says.
The GMP Letter