The FDA announced that it was issuing a Class I recall for Zimmer Spine's (ZMH) PEEK Ardis Inserter. A Class I recall is issued when the FDA believes that there is a reasonable probability that the use of a product could cause serious health problems. The device is used to insert Zimmer's PEEK Ardis Interbody Spacer during spinal surgery. Zimmer was told that the spacer has broken into fragments when too much lateral force is applied to the inserter in some cases, the FDA reported. As a result, patients may experience various adverse effects, including a tear in the thin covering of the spinal cord, cerebrospinal fluid leakage, significant blood loss and nerve injury, according to the agency. Long-term health risks may include disability, dysfunction, or death, it added. The FDA's recall was initiated on December 21. Zimmer, on December 20, had initiated a voluntary recall of all 315 of its PEEK inserter units. Zimmer said at that time that it had received reports of the spacer implant breaking, but did not list adverse health effects that could occur if the implant breaks. In early afternoon trading, Zimmer fell 38c, or 0.57%, to $66.35.
- Government Agencies