FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1706-2012
- Recalling firm
- Stryker Spine
- 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.
- Status
- Terminated
- Initiated
- 2012-01-12
- Posted
- 2012-06-05
- Terminated
- 2013-03-21
- 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
- Lot, serial or model codes
- Lot Codes (510k exempt): 07F116, 07F117, 085525, 086577, 086578, 087232, 087233, 088604.
- 510(k) numbers
- ["K071373"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3004024955
- Firm city
- Allendale
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28