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Zimmer, Inc. recalls Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) , Stainless Steel / Silicone Rubber, Rx
Recalled July 18, 2012 · FDA recall Z-1980-2012 · Zimmer
Hazard
Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been received that the rod holder tip may crack or break when the rod is manipulated during surgery. · FDA Class II
Units
249 ( angle handle and straight) in total
Sold at
Worldwide Distribution - USA (nationwide) and the countries of: Austria, Australia, Belgium, France, Gelmany, Italy, Spain, Switzerland and the United Kingdom.
Description
Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been received that the rod holder tip may crack or break when the rod is manipulated during surgery.
Product
Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) , Stainless Steel / Silicone Rubber, Rx only, non sterile. Product Usage: The rod is held by the instrument for inserting and guiding into the screw heads via percutaneous delivery during minimally invasive surgery to fuse the spine. Per the surgical technique (Ll554 Pathfinder NXT Surgical Technique);
Manufacturer(s)
Zimmer, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →