Product Wiki · Recalls · U.S. FDA — Device Enforcement

Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2… — recall Z-1981-2012

U.S. FDA — Device Enforcement · United States · 2012-06-05 · Class II

As described by U.S. FDA — Device Enforcement: 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 provi

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1981-2012
Date of alert
2012-06-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - USA (nationwide) and the countries of: Austria, Australia, Belgium, France, Gelmany, Italy, Spain, Switzerland and the United Kingdom.
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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