Z-1981-2012Class II

Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight handle) Stainless Steel /...

Name: Z-1981-2012 Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight handle) Stainless Steel /...
Creator: Zimmer, Inc.
Published: 2012-06-05
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-06-05 / Terminated / root cause: design

FDA source

Zimmer, Inc. began a recall of Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight handle) Stainless Steel / Silicone Rubber, Rx only, non sterile. Product Usage... on 2012-06-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1981-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-05
Posted: 2012-07-10
Terminated: 2014-09-03
Recalling firm: Zimmer GmbH
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 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.
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
Root cause tag: design
FDA root cause: Device Design
Action: Zimmer sent an Urgent Medical Device Correction and Removal notification dated June 5, 2012 to distributors and all affected accounts of Zimmer Spine. The notice identified the affected products, problem and actions to be taken. Distributors were asked to hand deliver Recall Notices to Surgeons and return the completed Surgeon Contact Certification Form within 10 working days to [email protected] or FAX to 1-512-258-0995. Notices to Surgeons and User facilities included revised directions/precautions for the Instructions for Use and attached Surgical Techique. Devices will be removed once newly design parts become available. For any related questions or assistance about this please contact Zimmer Spine Customer Service at 866-774-6368.
Quantity in commerce: 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.
Product codes and lots: Part numbers 3573-2 (straight handle) all lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1981-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1980-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-10
Z-1981-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-10

Product code NKB

K100845Class IIPathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc. / cleared 2010-09-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)