PlainRecalls
FDA Devices Moderate Class II Terminated

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 positio

Reported: July 18, 2012 Initiated: June 5, 2012 #Z-1981-2012

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.

Details

Recalling Firm
Zimmer, Inc.
Units Affected
249 ( angle handle and straight) in total
Distribution
Worldwide Distribution - USA (nationwide) and the countries of: Austria, Australia, Belgium, France, Gelmany, Italy, Spain, Switzerland and the United Kingdom.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Zimmer, Inc.. Units affected: 249 ( angle handle and straight) in total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 18, 2012. Severity: Moderate. Recall number: Z-1981-2012.

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