SpineFrontier Recalls S-LIFT Instrument Cases Due to Peeling Coating
SpineFrontier, Inc. is recalling 12 S-LIFT Instrument Cases because a bracket has a peeling nylon coating. The cases are used to hold surgical instruments for spinal fusion.
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. The hazard involves a peeling coating on a surgical instrument case, which is a quality defect without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
SpineFrontier, Inc. is recalling 12 units of the S-LIFT Instrument Case. These system cases are designed to hold and secure instrumentation used with surgical systems, specifically for intervertebral body fusion and spine fixation.
The recall is being issued because the instrument cases contained a bracket with a peeling nylon coating. The affected products are identified by lot numbers 7201.007 and 7201.007-1.
The recall covers distribution across the United States, including Florida, Colorado, Washington DC, Virginia, Kansas, Texas, Ohio, Tennessee, Oklahoma, California, Illinois, Missouri, and Minnesota. The source text does not specify instructions for consumers or healthcare providers regarding the disposition of these units.
The recalled product
- Product
- BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.
- Manufacturer
- SpineFrontier, Inc.
- Hazard
- Affected units
- 12
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/Serial Numbers: 7201.007 and 7201.007-1
Distribution
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