Stryker Receives Expanded FDA Warning for Unapproved Neptune Devices

Stryker received additional FDA warnings regarding its Neptune waste management systems. These devices were sold without clearance from the federal watchdog agency.In October of last year, Stryker issued a recall for its Neptune 1 Silver and its Neptune 2 Ultra. At that time, the company stated that the devices could cause damage to organs, muscles and soft tissues if used in an improper manner. Neither device had 510(k) clearance from the FDA.With new injury and death reports surfacing, the FDA has requested that physicians and healthcare providers stop using the Neptune devices. Stryker announced that it will discontinue its Neptune 1 and agreed to obtain clearance from the FDA for the Neptune 2.The company originally issued updated safety information to Neptune customers in February of this year. However, the devices continue to be misused, endangering patient safety.The FDA warning letter also chided the company for quality issues during an inspection of its production facility in Portage, Michigan. However, Stryker has not made any information available on these quality issues as of now.More news about Stryker:Stryker's FDA Troubles Equals Opportunity for Firm Selling Novel Waste Management DeviceStryker Buys VertiFlex's Spinal Implant Technology AssetsAfter Inspection, FDA Issues Warning Letter to StrykerStryker Completes Trauson Acquisition for $764 Million