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Stryker Receives FDA Warning Letter Following Class I Recall

 
• By Shawn M. Schmitt

The FDA letter cites Stryker for failing to notify FDA of a product recall and for illegally marketing devices, including the Neptune waste management system.

Stryker Corp. announced March 12 that it received a warning letter from FDA for quality system and marketing violations related to its Neptune waste management system, which was the subject of a class I recall.

The March 7 warning letter followed a November 2012 FDA inspection of the firm’s Stryker Instruments Portage, Mich., facility. The...

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