The FDA puts its highest-risk Class I label on the recall of DePuy Synthes' jaw stabilizing system over a defect that may result in injury or death in infants.
FDA regulators put their highest-risk Class I label on the recall of DePuy Synthes' Craniomaxillofacial Distraction System after the company reported 15 injuries associated with the jaw implant.
from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://ift.tt/1p8IFxz
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