SpineFrontier Recalls Three S-LIFT Slap Hammers Due to Malfunction
SpineFrontier, Inc. is recalling three S-LIFT Slap Hammers (Lot 56H26) distributed in Kansas and Texas because they malfunctioned.
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 source text cites a malfunction but does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall involving a potential risk of harm without reported adverse events.
Plain-English summary
SpineFrontier, Inc. is recalling three units of the S-LIFT Slap Hammer, Part Number 11-50204, Revision A. These devices are used primarily to remove trial instruments that estimate the sizes of intervertebral body fusion devices intended to promote fusion in skeletally mature patients.
The recall was initiated due to a malfunction of the slap hammer. The affected units are identified by Lot 56H26.
The recalled devices were distributed in the United States to the states of Kansas and Texas. No specific instructions for consumers or healthcare providers are provided in the source text.
The recalled product
- Product
- S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar…
- Manufacturer
- SpineFrontier, Inc.
- Hazard
- Affected units
- 3
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: 56H26
Distribution
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