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.
What this means for you
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
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