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Friday, Dec 28
2012, 12:13 PM
The FDA has classified a recent recall of Zimmer's (ZMH -0.8%) Peek Ardis Inserter as Class I,...
The FDA has classified a recent recall of Zimmer's (ZMH -0.8%) Peek Ardis Inserter as Class I, suggesting the product could cause serious health consequences or death. ZMH issued a recall on December 20, after reports of the Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter. At the time ZMH warned that if the 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, cerebrospinal fluid leakage, significant blood loss and nerve injury.