Z-1981-2012 Class II Terminated
FDA device recall Z-1981-2012 was initiated by Zimmer, Inc. on Jun 5, 2012 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Sep 3, 2014). Affected quantity: 249 ( angle handle and straight) in total.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 18, 2012
- Initiation Date
- Jun 5, 2012
- Termination Date
- Sep 3, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 249 ( angle handle and straight) in total
Product Description
Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight handle) Stainless Steel / Silicone Rubber, Rx only, non sterile. Product Usage: PathFinder NXT is a minimally invasive pedicle screw system. The PathFinder NXT System consists of various screws and rods intended to provide temporary stabilization following surgery to fuse the spine. The intended use of the Fixed Angled Percutaneous Rod Inserter is to insert a rod percutaneously through the extender sieeves to position into the implanted screw heads for securing with closure tops forming a construct that provides temporary stabilization following MIS or mini-open surgery to fuse the spine.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of: Austria, Australia, Belgium, France, Gelmany, Italy, Spain, Switzerland and the United Kingdom.
Code Information
Part numbers 3573-2 (straight handle) 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-1981-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026