Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
KYPHON EXPRESS Recalled by Medtronic Sofamor Danek USA Inc Due to The product, labeled as containing, one bevel-tipped instrument...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Sofamor Danek USA Inc directly.
Affected Products
KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.
Quantity: 239 units
Why Was This Recalled?
The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Sofamor Danek USA Inc
Medtronic Sofamor Danek USA Inc has 81 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report