Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Stryker UniVise Spinous Process Fixation Plate System Inserter Recalled by Stryker Spine Due to The Inserter Inner Shaft would not fit through...
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 Stryker Spine directly.
Affected Products
Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
Quantity: 41 units
Why Was This Recalled?
The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Stryker Spine
Stryker Spine has 29 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report