Spine Smith VisuALIF PEEK Block Recall Due to Potential Sizing Mislabeling
Spine Smith Holdings is recalling 32 VisuALIF PEEK blocks because they may be marked as Medium when they are actually Small.
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 hazard is a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Spine Smith Holdings, LLC is recalling 32 units of the VisuALIF system, a 'U' shaped PEEK block intended for implantation via an open anterior approach. The specific part number is 0301-1410, and the affected lot is 53AR. These devices were distributed in Florida.
The recall was initiated because the product has the potential to be laser marked as a Medium size when it is actually a Small size. This labeling discrepancy could lead to the implantation of an incorrectly sized device.
Healthcare providers and patients who have received or are considering this specific lot of VisuALIF blocks should contact Spine Smith Holdings, LLC for further instructions on how to proceed.
The recalled product
- Product
- VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach.
- Manufacturer
- Spine Smith Holdings, LLC
- Hazard
- Affected units
- 32
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 (2)
- Part Number: 0301-1410
- Lot 53AR
Distribution
Distributed in 1 state:
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