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Zimmer recall gets FDA's highest-risk Class I status | MassDevice.com On Call

Tue, 01/01/2013 - 7:29am
Mass Device

The FDA slaps Zimmer with Class I status for a global medical device recall of spinal surgery instruments.

MassDevice On Call

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.

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