The Recall Desk
SevereFDA (Devices)·Z-1981-2012·Announced 2012-07-18

Zimmer Recalls Pathfinder NXT Fixed Percutaneous Rod Holder Due to Cracking

Zimmer, Inc. is recalling the Pathfinder NXT Fixed Percutaneous Rod Holder because the tip may crack or break during surgery.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a surgical instrument that could break during a procedure, posing a risk of significant injury.

Plain-English summary

Zimmer, Inc. is recalling the Pathfinder NXT Fixed Percutaneous Rod Holder, part number 3573-2 (straight handle). The device is a stainless steel and silicone rubber component used in the PathFinder NXT minimally invasive pedicle screw system to provide temporary stabilization following spine surgery.

The recall was initiated because complaints were received indicating that the rod holder tip may crack or break when the rod is manipulated during surgery. The recall includes 249 units in total, covering both angle and straight handles, with all lots of part number 3573-2 affected.

The affected devices were distributed worldwide, including the United States (nationwide) and Austria, Australia, Belgium, France, Germany, Italy, Spain, Switzerland, and the United Kingdom. Healthcare providers should stop using the affected devices and contact Zimmer, Inc. for further instructions.

The recalled product

Product
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 ro
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Surgical Instrument
Hazard
Affected units
249

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Part numbers 3573-2 (straight handle) all lots.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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