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Hospitals
FDA warns Signal Medical on unapproved hip implants
By Brad Perriello The FDA sends a warning letter to Signal Medical, flagging it for making unapproved changes to its…
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Hospitals
FDA issues warning letter to Smith & Nephew regarding questionable operations at plant in Andover, MA
By Varun Saxena The FDA slapped Smith & Nephew ($SNN) with a warning letter for quality-control violations at its Andover,…
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Spine
Warning Letter for Spinal Elements
[gview file=”https://orthospinenews.com/wp-content/uploads/2014/07/Spinal-Elements.pdf” save=”1″]
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Spine
Anulex Technologies, Inc. Resolves FDA Warning Letter
MINNETONKA, Minn.–(BUSINESS WIRE)–Anulex Technologies, Inc., a privately held medical device manufacturer, has announced the U.S. Food and Drug Administration (FDA)…
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Vertiflex Spine receives warning letter for Dynabolt and Silverbolt
WARNING LETTER CERTIFIED MAIL RETURN RECEIPT REQUESTED W/L 30-10 July 14, 2010 Earl R. Fender President and CEO VertiFlex, Inc.…
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Surgeons Warn Of Problems With Zimmer Knee Product
Three surgeons on Thursday recommended against implanting a certain Zimmer Holdings Inc. (ZMH: 58.43, 1.43, 2.51%) replacement knee product because…
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Stryker Says One Of Four FDA Warning Letters Now Resolved
Stryker Corp. (SYK) has resolved one of four warning letters issued by the Food and Drug Administration in recent years…
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