Z-1933-2012 Class II Terminated
FDA device recall Z-1933-2012 was initiated by Zimmer, Inc. on Jun 5, 2012 and is designated Class II. 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… The recall status is terminated (terminated Feb 14, 2013). Affected quantity: 77 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 11, 2012
- Initiation Date
- Jun 5, 2012
- Termination Date
- Feb 14, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 77 units
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
Distribution Pattern
Worldwide distribution: USA (nationwide) and countries of: Australia, France and Germany.
Code Information
Part number 3564-1; all lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1933-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026