Recall Z-2722-2011 ยท HXX Screwdriver
Zimmer Inc.
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 an
| Date | Jul 6, 2011 (initiated May 20, 2011) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 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. |
| 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 |