The FDA slaps Zimmer with Class I status for a global medical device recall of spinal surgery instruments.
MASSDEVICE ON CALL — The FDA slapped medical device giant Zimmer Holdings (NYSE:ZMH) with Class I status for a global recall of the company's PEEK Ardis Inserter instruments over concerns that the devices could cause issues during surgery.
Zimmer initiated the recall last month after receiving reports that the inserters may put too much pressure on the Ardis Interbody Spacers, fracturing the spinal devices during implant.
"If the PEEK Ardis Interbody Spacer breaks during implantation, surgical delays of up to 60 minutes could occur and health risks may include a tear in the thin covering of the spinal cord (dural tear), cerebrospinal fluid leakage, significant blood loss and nerve injury. Long-term health risks may include disability, dysfunction, or death," according to the FDA notice.
Long-term risks include disability, dysfunction or death, the FDA added.
Zimmer initiated the recall just a few weeks ago after the device maker received reports, which suggested a fracture occurrence rate of 0.52%, according to the company.
The recall includes certain lots distributed from June 2008 to December 2012. The full list of affected part numbers is available from Zimmer's site.
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