Recall Z-1706-2012 ยท NKB Thoracolumbosacral Pedicle Screw System
Stryker Spine
Stryker Xia 3 Anti-Torque Key Manual Surgical Instrument; Catalog Number 48237026. Product Usage: : Reusable instrument used to aid in the final tightening of the spinal construct. Intended Use: The Anti-Torque Key allows the Torque Wrench to align with the tightening axis and maximizing the torque needed to lock the implant assembly during final tightening of the spinal construct.
| Date | Jun 5, 2012 (initiated Jan 12, 2012) |
| Status | Terminated |
| Reason | Stryker received four reports regarding a handle which separates at the point where it is welded to the shaft on the Xia 3 Anti-Torque Key during surgery. |
| Root cause | Mixed-up of materials/components |
| Action | Stryker Spine sent an Urgent Product Recall letter dated January 12, 2012 with an attached Customer Response forms via FEDEX to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine their inventory to identify the affected product and return using the prepaid mailing label provided. The letter asked customers to complete the Customer Response Form and fax to 201.760.8370. For questions call 201.760.8298. |
| Quantity | 95 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071373 | STRYKER SPINE XIA III SPINAL SYSTEM Stryker Spine, Aug 27, 2007 |