|The FDA slapped a Class I label on Zimmer's recall of the PEEK Ardis implanter--courtesy of Zimmer|
Last week, Zimmer ($ZMH) launched a worldwide recall of its PEEK Ardis spinal surgery tool, and now the FDA has slapped a Class I tag on the effort, warning that use of the device could result in serious injury or death.
The device is used to implant Zimmer's PEEK Ardis Interbody Spacer during spinal surgery, but the company says the insertion may break the spacer during spinal procedures, delaying the process and possibly leading to blood loss and nerve injury. In worst-case scenarios, spinal injury can lead to disability, dysfunction and death, the FDA warns.
Zimmer is recalling all 315 units out there, and the spacers can't be implanted with any other devices, so Zimmer's spinal implants are basically on hold until the company can get FDA clearance for another tool.
In the meantime, the FDA is asking customers to report adverse events through its MedWatch system, and Zimmer is asking surgeons to return all the devices at once. The company has launched a website to inform doctors and handle the recall process, available here.
This latest regulatory hiccup comes after Zimmer ran afoul of the FDA over its hip implant manufacturing, resulting in an October warning letter chiding the company for its practices at a Puerto Rican plant.
- here's the FDA notice