Endotec Inc., based in South Orange, N.J., has received a warning letter from the U.S. Food and Drug Administration (FDA), saying that the company's facilities do not meet good manufacturing practice requirements.

Additionally, the letter stated a complaint reported a malfunction of Tibial Platform Size 4 Type 1, where the pin stop of the tibial platform fell out during surgery. An FDA probe revealed the mating holes were oversized, causing the pin stop to fall out, the agency said.

For the complete warning letter, visit www.fda.gov/ICECI/EnforcementActions/ WarningLetters/ucm193670.htm.