|The FDA issued Stryker a warning letter for improperly marketing devices, including Neptune.--Courtesy of the FDA|
The FDA is warning of additional death and injury reports related to Stryker's ($SYK) Neptune waste management systems, devices the company sold without agency clearance.
Stryker issued a recall of the Neptune 1 Silver and Neptune 2 Ultra back in October, saying the devices could damage soft tissues, organs and muscles if used improperly. The company marketed the two devices without ever obtaining 510(k) clearance from the FDA, an infraction name-checked in the warning letter Stryker received last week.
In light of the new death and injury reports, the agency is echoing its call for physicians to stop using Neptune and transition to approved devices. Stryker plans to discontinue the Neptune 1 and is working with the agency to finally get clearance for the second generation of the device.
The new reports are of particular concern to Stryker and the agency, because the company issued an update to customers on Neptune's safety information back in February, meaning operators are still misusing the device and putting patients at risk, according to the FDA.
Last week's warning letter chided Stryker for selling Neptune and other devices without clearance, and cited the company for quality system failings observed during an inspection of its Portage, MI, facility this year, but the company has remained largely silent on the extent of the problems, and the FDA is yet to post the full letter.
Stryker spokesman Joe Cooper didn't elaborate on the warning but said Stryker has already submitted corrective action plans for the quality problems and should be able to rectify the issue in 6 to 9 months.
- read the FDA's note