Z-1706-2012

Stryker Xia 3 Anti-Torque Key Manual Surgical Instrument; Catalog Number 48237026

Name: Z-1706-2012 Stryker Xia 3 Anti-Torque Key Manual Surgical Instrument; Catalog Number 48237026
Creator: Stryker Spine
Published: 2012-01-12
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2012-01-12 / Terminated / root cause: manufacturing process

FDA source

Stryker Spine began a recall of Stryker Xia 3 Anti-Torque Key Manual Surgical Instrument; Catalog Number 48237026. Product Usage: : Reusable instrument used to aid in the final tightening of... on 2012-01-12. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1706-2012
Status: Terminated
Initiated: 2012-01-12
Posted: 2012-06-05
Terminated: 2013-03-21
Recalling firm: Howmedica Osteonics Corp
Product: 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.
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 95 units
Distribution: US Nationwide Distribution
Product codes and lots: Lot Codes (510k exempt): 07F116, 07F117, 085525, 086577, 086578, 087232, 087233, 088604.

Product code NKB

K071373Class IIStryker Spine Xia III Spinal SystemStryker Spine / cleared 2007-08-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)