Vertebral Technologies Recalls InterFuse Tail Traction Tool Due to Fit Issues
Vertebral Technologies is recalling 63 InterFuse Tail Traction Tools because they may not fit properly with the InterFuse T implant.
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, which typically corresponds to a moderate severity score. The hazard involves a mechanical fit issue that could affect the procedure, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Vertebral Technologies, Inc. is recalling 63 units of the InterFuse Tail Traction Tool, Part Number 9116. This optional Class I non-sterile reusable instrument is used to assist with module locking of the InterFuse S or InterFuse T implant systems.
The recall was initiated because fit issues were identified with the tool when used with the InterFuse T tailed implant. Specifically, the InterFuse T Tail may not fit into the Thru Hole in the instrument. The affected units are distributed across 11 US states and 10 countries, including Italy, Canada, and Brazil.
Healthcare providers and facilities that have received these instruments should stop using them and contact Vertebral Technologies for further instructions. The recall covers specific lot numbers, including 110512-02 and 110718-01.
The recalled product
- Product
- InterFuse Tail Traction Tool, Part Number 9116. The InterFuse Tail Traction Tool is an optional Class I non-sterile reusable instrument that can be used to assist with module locking of the InterFuse S or InterFuse T implant system. The system has a modular design to allow…
- Manufacturer
- Vertebral Technologies, Inc.
- Affected units
- 63
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 (8)
- Lot: 110512-02
- 110718-01
- 110831-02
- 120214-01
- 120403-018
- 120420-07
- 120711-02
- 120911-06
Distribution
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