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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- Manufacturer
- Zimmer, Inc.
- 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.
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