Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique Recalled by SpineFrontier, Inc. Due to The PedFuse Pedicle Screw Rod Caliper included with...
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
SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior pedicle screw fixation.
Quantity: 5 devices
Why Was This Recalled?
The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design.
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