Endotec Warned for Investigation, Design Validation Failures

Orthopedic devicemaker Endotec has been warned for several good manufacturing practice 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 posted to the FDA’s website last month. The pin stop malfunction has occurred previously, it adds.
The GMP Letter