Zimmer Recalls PathFinder NXT Pivoting Percutaneous Rod Holder
Zimmer, Inc. is recalling 77 units of the PathFinder NXT Pivoting Percutaneous Rod Holder because the set screw may break, preventing the surgeon from removing the rod 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where the device failure could impede surgery, but the source explicitly states that no patient or user injuries have been reported.
Plain-English summary
Zimmer, Inc. is recalling 77 units of the PathFinder NXT Pivoting Percutaneous Rod Holder, an instrument used during orthopedic surgery to facilitate rod insertion and positioning. The recall covers part number 3564-1, all lots. The devices were distributed worldwide, including the United States, Australia, France, and Germany.
The recall was initiated after complaints were reported where surgeons were unable to loosen or remove the inserted rod from the holder during surgery. Investigations revealed that the hex mating feature of the set screw was broken with material missing. The source text notes that there were no reports of set screw fragments being left in patients or any patient or user injury.
Healthcare providers should stop using the affected devices and contact Zimmer, Inc. for further instructions. Consumers are not directly affected as this is a professional medical device used in surgical settings.
The recalled product
- Product
- 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…
- Manufacturer
- Zimmer, Inc.
- Affected units
- 77
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 (2)
- Part number 3564-1
- all lots
Distribution
Distributed nationwide across the United States.
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