Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PedFuse Reset Screw Recalled by SpineFrontier, Inc. Due to During routine servicing, it was discovered that one...
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
PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
Quantity: 35 Devices
Why Was This Recalled?
During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity.
Where Was This Sold?
This product was distributed to 2 states: TX, VA
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