SpineFrontier Recalls 13 PedFuse Bone Probes Marked to Incorrect Specifications
SpineFrontier, Inc. is recalling 13 PedFuse Bone Probes used for spinal pedicle fixation because they were manufactured and marked to incorrect specifications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a manufacturing and marking error without reporting any specific injuries, illnesses, or deaths. This aligns with the rubric for moderate severity, representing a potential risk or labeling error without confirmed harm.
Plain-English summary
SpineFrontier, Inc. is recalling 13 units of the PedFuse Bone Probe, part number SI81008, used for spinal pedicle fixation. The recall was initiated because the devices were manufactured and marked to incorrect specifications.
The affected devices were distributed in the United States, specifically in the states of Texas and Virginia. The lot number for the recalled devices is 012212-001.
Healthcare providers and facilities that have received these devices should stop using them and contact SpineFrontier, Inc. for instructions on how to return or dispose of the products. Patients who have had these devices implanted should contact their healthcare provider for further guidance.
The recalled product
- Product
- PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
- Manufacturer
- SpineFrontier, Inc.
- Affected units
- 13
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 012212-001
Distribution
Related recalls
Same manufacturer · SpineFrontier, Inc.
See all →- HighSpineFrontier Recalls A-CIFT SoloFuse Fixed Angle Driver Due to Binding Risk
FDA (Devices) · 2019-07-24
- ModerateSpineFrontier Recalls MISquito Pedicle Screw System Surgical Technique Document
FDA (Devices) · 2015-04-29
- HighSpineFrontier Recalls Inline Persuader Pedicle Screw System Due to Handle Crack
FDA (Devices) · 2015-01-21
- SevereSpineFrontier S-Lift Lock Shaft Inserter Recalled for Potential Breakage
FDA (Devices) · 2014-05-14
- ModerateSpineFrontier Recalls Arena-L Trial Heads Due to Compatibility Issues
FDA (Devices) · 2014-01-22
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateSpineFrontier Recalls PedFuse Reset Pedicle Screws Due to Assembly Error
FDA (Devices) · 2013-12-25
- HighSpineFrontier Recalls Inline Persuader Pedicle Screw System Due to Handle Crack
FDA (Devices) · 2015-01-21
- HighSpineFrontier Recalls PedFuse Screw Caddies Due to Misaligned Screw Compartments
FDA (Devices) · 2013-08-07
- HighSpineFrontier Recalls KRD1 PedFuse Rods Due to Fatigue Testing Failures
FDA (Devices) · 2013-07-24
- ModerateSpineFrontier Recalls PedFuse Screw Inserters Due to Mating Defect
FDA (Devices) · 2014-01-01
- HighSpineFrontier Recalls Rev E PedFuse Return Screw Inserters Due to Loose Set Screw
FDA (Devices) · 2013-08-14