FDA: Class I recall of Zimmer Biomet spinal fusion, long bone stimulators
Editor's Note The Food & Drug Administration (FDA) on November 26 identified the recall by Zimmer Biomet (Warsaw, Indiana) of its Osteogen Implantable Bone Growth Stimulator, SpF PLUS-Mini Implantable Fusion Stimulator, and SpF-XL Implantable Spinal Fusion Stimulator as Class I, the most serious. The recall was initiated because of the…
FDA plans big changes to 510(k) pathway
Editor's Note The Food and Drug Administration (FDA) on November 26 announced that it plans to modernize its 510(k) approval pathway by pushing device manufacturers to rely on predicate devices that are not older than 10 years. Under the existing pathway, manufacturers can pursue expedited approval for devices that are…
FDA: Fresenius Kabi recalls sodium chloride injection
Editor's Note The Food and Drug Administration (FDA) on November 20 announced the nationwide recall by Fresenius Kabi USA (Lake Zurich, Illinois) of 163 lots of sodium chloride injection, USP, 0.9%, 10 mL and 20 mL vials. The recall was initiated because the product insert incorrectly states that the vial…
FDA launches app for EHR data collection
Editor's Note The Food & Drug Administration (FDA) recently launched a new app to help streamline electronic health record (EHR) data collection for researchers, The November 7 EHR Intelligence reports. Using the MyStudies app, researchers can access patient-generated health data, EHR patient data, and claims and billing information for use in…
FDA guidance updates UDI compliance policy
Editor's Note The Food & Drug Administration on November 5 released the guidance, “Unique Device Identification: Policy Regarding Compliance dates for Class I and Unclassified devices and Certain Devices Requiring Direct Marking,” which takes effect immediately. The new guidance includes updated Unique Device Identification (UDI) direct mark requirements and supersedes…
FDA: Class I recall of Cardiosave Hybrid and Rescue IABPs
Editor's Note The Food & Drug Administration on November 2 identified the recall by Maquet Datascope Corp/Getinge Group’s Cardiosave Hybrid and Cardiosave Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious. The recall was initiated because of the potential for the autofill process to malfunction or fail during…
FDA: Class I recall of CyPass Micro-Stent Systems
Editor's Note The Food & Drug Administration (FDA) on October 24 classified Alcon Research’s recall of its CyPass Micro-Stent Systems as Class I, the most serious. The recall was initiated because of the risk of corneal endothelial cell loss with the system, which is used in conjunction with cataract surgery…
FDA: Safety Communication on Raindrop Near Vision Inlay
Editor's Note The Food & Drug Administration (FDA) on October 23 issued a Safety Communication on the increased risk of corneal haze associated with the Raindrop Near Vision Inlay, which is surgically implanted in the cornea of one eye to improve near vision. The notice is to alert eye care…
FDA: Promise Pharmacy recalls one lot of Prednisolone, Gatifloxacin Ophthalmic Solution
Editor's Note The Food & Drug Administration (FDA) on October 22 announced the recall by Promise Pharmacy (Palm Harbor, Florida) of one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3 mL vials (Lot Number 09042018@2, Exp 12/03/2018). The recall was issued because the product was found to have…
FDA: Class I recall of Endologix AFX Endovascular AAA System
Editor's Note The Food & Drug Administration on October 15 classified the recall by Endologix, Inc, of its AFX Endovascular AAA System as Class I, the most serious. The recall was initiated because of the risk of Type III endoleaks. When a Type III endoleak occurs, blood continues to flow…
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