Recall Z-1933-2012 ยท NKB Thoracolumbosacral Pedicle Screw System
Zimmer, Inc.
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 th
| Date | Jul 3, 2012 (initiated Jun 5, 2012) |
| Status | Terminated |
| Reason | 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 | 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 com |
| Quantity | 77 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Australia, France and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100845 | PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES Zimmer Spine, Inc., Sep 21, 2010 |