Recall Z-3162-2011 ยท NKB Thoracolumbosacral Pedicle Screw System
Orthofix, Inc.
Ratcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal Implants, Firebird Spinal Fixation System, Firebird Spinal Fixation System DDD Instrument Case. Product is intended for use with the Set Screw Driver (52-1061) and Adjustable Counter Torque Wrench (52-1265) to perform the final tightening of set screws in a spinal implant construct.
| Date | Sep 7, 2011 (initiated Apr 1, 2011) |
| Status | Terminated |
| Reason | Upon reaching torque limit, there is a possibility the product may jam or exhibit a ratchet direction switch from forward to reverse. |
| Root cause | Device Design |
| Action | Orthofix, Inc. sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated April 1, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to identify and remove the affected product from use. Customers were advised to use the combination of the Ratching R Handle and the Set Screw Driver if they experience problems with the Ratching Torque Limiting Handle. A Tracking and Verification form was attached for customers to complete and return to the Orthofix Inc. Regulatory Affairs Department via fax a |
| Quantity | 287 units |
| Distribution | Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Australia and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092624 | FIREBIRD SPINAL FIXATION SYSTEM Blackstone Medical, Inc., Sep 25, 2009 |