SpineFrontier Recalls S-LIFT Inserter Outer Sleeve Due to Fit Issue
SpineFrontier, Inc. is recalling 12 S-LIFT Inserter Outer Sleeves because the handle hole is too small to fit the assembly.
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 defect is a mechanical fit issue that prevents the instrument from being used, but the source text does not report any injuries, illnesses, or deaths.
Plain-English summary
SpineFrontier, Inc. is recalling 12 units of the S-LIFT Inserter Outer Sleeve, model SI50003 RevA. The product is an optional instrument used to add compression during the implantation of S-LIF Intervertebral Body Fusion Devices.
The recall was initiated because the hole at the top of the sleeve handle is too small, preventing the outer sleeve from fitting over the S-LIFT Inserter assembly. This defect prevents the instrument from being used as intended.
The affected devices were distributed nationwide in the United States, including in Florida, Texas, Oklahoma, Missouri, New Jersey, and Massachusetts. The specific lot number is 47175. Users should stop using the affected devices and contact the manufacturer for instructions.
The recalled product
- Product
- S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Fusion Devices using bone graft to facilitate fusion of the spine of…
- 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: 47175
Distribution
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