Z-1933-2012Class II

PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery...

Name: Z-1933-2012 PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery...
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 Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery. The intended use of the pivoting percutaneous rod... on 2012-06-05. FDA classified it as Class II and gives the reason as "Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove the inserted rod from the rod holder instrument. The complaint investigation showed the hex mating feature of the set screw...". 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-1933-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-05
Posted: 2012-07-03
Terminated: 2013-02-14
Recalling firm: Zimmer GmbH
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 sleeves, under the fascia. The rod is secured to the holder by tightening a captive set screw against the rod end in the tip of the holder using the set screw driver. After positioning the rod and securing at least one pedicle screw closure top against the implanted rod, the holder is removed from the rod end by loosening the captive set screw with the set screw driver.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove the inserted rod from the rod holder instrument. The complaint investigation showed the hex mating feature of the set screw was broken and material missing. There were no reports of fragments of the set screw being left in the patient or that there was any patient or user injury, but these events we
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Zimmer Spine, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 5, 2012 to all consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to review the notification and ensure they are aware of the content; to immediately remove and discontinue use of Pivoting Percutaneous Rod Holder (part number 3564-1) from Pathfinder NXT instrument sets in their possession and follow the PathFinder NXT Surgical Technique; to notify their Zimmer Spine customer service representative to obtain return authorization; and return the complete Surgeon Contact Certification Form within 10 working days from receipt of notification to [email protected] or Fax to 1-512-258-0995. If you have any questions, call Zimmer Spine Customer Service at 866-774-6368.
Quantity in commerce: 77 units
Distribution: Worldwide distribution: USA (nationwide) and countries of: Australia, France and Germany.
Product codes and lots: Part number 3564-1; all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1933-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1933-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-07-03

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)