Z-2722-2011

Pathfinder NXT Closure top driver - long, REF 3566-1, Zimmer Inc., Warsaw, IN

Name: Z-2722-2011 Pathfinder NXT Closure top driver - long, REF 3566-1, Zimmer Inc., Warsaw, IN
Creator: Zimmer Inc.
Published: 2011-05-20
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-05-20 / Terminated / root cause: design

FDA source

Zimmer Inc. began a recall of Pathfinder NXT Closure top driver - long, REF 3566-1, Zimmer Inc., Warsaw, IN Product Usage: The Closure Top Driver is used in conjunction with compressors... on 2011-05-20. The reason FDA records is "Zimmer Spine, Inc. is initiating a voluntary recall regarding an increased risk of rounding or partial rounding of the hex tip on the 3566-1 (long) and 3566-2 (short) Closure Top Driver used for insertion, provisional...". 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-2722-2011
Status: Terminated
Initiated: 2011-05-20
Posted: 2011-07-06
Terminated: 2011-10-07
Recalling firm: Zimmer GmbH
Product: Pathfinder NXT Closure top driver - long, REF 3566-1, Zimmer Inc., Warsaw, IN Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to manipulate and hold the spine into the desired position via loosening/tightening maneuvers on the provisionally inserted closure tops of the construct assembly. After confirmation of correct screw and rod placement, the Closure Top Driver is used to apply final torque to the provisionally tightened closure tops to secure the construct assembly. The Closure Top Driver is also used to remove previously inserted closure tops during construct removal.
Product code: HXX Screwdriver
Reason for recall: Zimmer Spine, Inc. is initiating a voluntary recall regarding an increased risk of rounding or partial rounding of the hex tip on the 3566-1 (long) and 3566-2 (short) Closure Top Driver used for insertion, provisional tightening, and final locking of Closure Tops during the screw and rod construct assembly of the Pathfinder NXT Pedicle Screw System. When the hex tip of the Closure Top Driver is
Root cause tag: design
FDA root cause: Device Design
Action: Zimmer, Inc. issued an "URGENT MEDICAL DEVICE RECALL" letters dated April 2011, to all affected customers. The letter identified the product, problem and actions to be taken. The customers were instructed that (THE GOLD CLOSURE TOP DRIVERS 3566-1 and 3566-2 ARE NOT TO BE USED FOR FINAL TIGHTENING); an alternate instrument for final construct tightening will be included in the instrument set 3570-1 short and 3570-2 long (These instruments are silver instead of gold for easy identification and do not include a retention feature for holding the Closure Top); to ensure final drivers are added to each PathFinder NXT set and inspect Closure Top Drivers for rounded hex wear; contact their customer service representative if they do not have both versions; and complete and return all attached forms via fax to: Zimmer Spine at 512-258-0995. The letter states that the firm will revise the surgical technique to show the updated uses of the screwdrivers. Please keep Zimmer Spine informed of any adverse events associated with the device or any other Zimmer spine product by calling 800-326-0635. For any further questions or concerns contact the Vice President Quality Assurance & Regulatory Affairs at 800-655-2614.
Quantity in commerce: 134 devices
Distribution: Worldwide Distribution -- USA (nationwide) including states of: AZ, CA, WI, MI, KS, OK, TX, GA, TN, FL, NJ, CT, PA and the countries of: Australia and Italy.
Product codes and lots: REF 3566-1 Lots 62TP, 63SG, 65DE, 66CH.

Product code HXX

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)