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Home Current Issue Article Archives 2010 Buyers Guide Company Capabilities Latest News Meetings & Events Logo Link Manufacturers Gallery Web Showcase Literature Showcase Subscription Services Media Planner Advertising Contacts:Howard Revitch201-825-2552 x343 Mark Weeks732-961-0885 Patrick Browne908-859-8431 Julie Steinkrauss Fuhrer781-863-0400 Carolyn Dale512-494-5943 Editorial Contacts:Chris Delporte201-825-2552 x358 Michael Barbella201-825-2552 x344 Privacy Statement |
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Latest NewsFDA: Endotec Didn't Follow Good Manufacturing Practice RequirementsEndotec 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. |
