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.
- Company
- Stryker Spine
- Recall Initiated
- January 12, 2012
- Posted
- June 5, 2012
- Terminated
- March 21, 2013
- Recall Number
- Z-1706-2012
- Quantity
- 95 units
- Firm Location
- Allendale, NJ
Reason for Recall
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.
Distribution
US Nationwide Distribution
Lot / Code Info
Lot Codes (510k exempt): 07F116, 07F117, 085525, 086577, 086578, 087232, 087233, 088604.
Root Cause
Mixed-up of materials/components
Action Taken
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.