Recall Z-1933-2012— Zimmer, Inc.

Name: FDA recall Z-1933-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-05

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2012-06-05, terminated 2013-02-14. It names one FDA 510(k) clearance: K100845. 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.. Reason: 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.

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-06-05
Terminated: 2013-02-14
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K100845 — PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIESZimmer Spine, Inc.·cleared 2010-09-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.