Recall Z-0034-2012 ยท FZS Curette, Surgical, General Use
X Spine Systems Inc
Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
| Date | Oct 11, 2011 (initiated Jul 15, 2011) |
| Status | Terminated |
| Reason | The firm learned that the Torque Driver Handles were not actuating at a proper torque. It was determined that the handles were speed determinant and could output a higher torque if the handles were turned at a very slow speed. |
| Root cause | Component design/selection |
| Action | X-spine Systems, Inc. sent an URGENT DEVICE RECALL letter dated September 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their stock immediately to determine if they have any affected product. If so, customers were instructed once the set screw is tightened onto the locking plate, and resistance is detected in the handle, it will take less than 2 seconds to hear the handle "click." The "click" indicates the torque limit was reached. If further resistance is felt after 2 s |
| Quantity | 39 Torque Driver Handles |
| Distribution | Nationwide Distribution including CA, CO, FL, IA, IN, LA, NY, PA, TN, TX and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101471 | AXLE INTERSPINOUS FUSION SYSTEM X-Spine Systems, Inc., Nov 24, 2010 |