A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
The FDA has issued a Class I Recall for Mizuho Orthopedic Systems’ OSI Modular Table Systems. The incorrect removal of T-pins that support the bottom base, instead of the T-pins that support the top, may result in the lower table top and patient falling to the floor.