FDA: Class I recall of PROFEMUR modular neck prostheses
Editor's Note The Food and Drug Administration on October 2 categorized the recall of PROFEMUR Neck Varus/Valgus CoCr 8 degree, Part number PHAC 1254, by MicroPort Orthopedics as Class I, the most serious. The company has received reports of unexpected fractures after surgery related to this modular neck. If the…
FDA labels recall of Medtronic’s heart valve loading system Class I
Editor's Note The Food and Drug Administration on August 5 categorized the recall of 6,912 units of Medtronic Cardiovascular Surgery’s EnVeo R loading system as Class I, the most serious. The loading system is used with the CoreValve Evolut R replacement heart valve. The recall was issued over concerns about…
First step taken in FDA-issued unique device identification system
Medical device manufacturers have taken the first step in complying with the 7-year unique device identification (UDI) process mandated by the Food and Drug Administration (FDA). The UDI system establishes a consistent way to label and track medical devices from production to use, and is intended to improve patient safety…
Stryker's Neptune recall raises stakes for compliance
Strict requirements needed to comply with a recall for the Neptune brand of roving suction devices are raising questions and concern for ORs whose facilities continue to use the devices. The recall of the Neptune Waste Management System from Stryker, used to collect and dispose of fluid waste, was initiated…
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