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Zimmer, Inc. recalls PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery. The inte
Recalled July 11, 2012 · FDA recall Z-1933-2012 · Zimmer
Hazard
Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove the inserted rod from the rod holder instrument. The complaint investigation showed the hex mating feature of the set screw was broken and material missing. There were no reports of fragments of the set screw being left in the patient or that there was any patient or user injury, but these events we · FDA Class II
Units
77 units
Sold at
Worldwide distribution: USA (nationwide) and countries of: Australia, France and Germany.
Description
Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove the inserted rod from the rod holder instrument. The complaint investigation showed the hex mating feature of the set screw was broken and material missing. There were no reports of fragments of the set screw being left in the patient or that there was any patient or user injury, but these events we
Product
PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery. The intended use of the pivoting percutaneous rod holder is to attach to the rod to facilitate rod insertion, positioning, and orientation through the extender sleeves, under the fascia. The rod is secured to the holder by tightening a captive set screw against the rod end in the tip of the holder using the set screw driver. After positioning the rod and securing at least one pedicle screw closure top against the implanted rod, the holder is removed from the rod end by loosening the captive set screw with the set screw driver.
Manufacturer(s)
Zimmer, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →