Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
InSpan Inserter Recalled by SpineFrontier, Inc. Due to Potential for set screw to be come deformed.
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 SpineFrontier, Inc. directly.
Affected Products
InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan Spinous Plate System for the purpose of achieving supplemental fixation.
Quantity: 61 individual inserter assemblies
Why Was This Recalled?
Potential for set screw to be come deformed.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SpineFrontier, Inc.
SpineFrontier, Inc. has 33 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report