SpineFrontier Recalls Arena-L Trial Heads Due to Compatibility Issues
SpineFrontier, Inc. is recalling 23 Arena-L 35x26 Trial Heads because they may not be compatible with the trial handles.
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 source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity recall involving a functional defect.
Plain-English summary
SpineFrontier, Inc. is recalling 23 Arena-L 35x26 Trial Heads, part numbers 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, and 11-81004-16. These trial heads are smooth plates made of 17-4 Stainless Steel, designed to mimic the footprint of the implant and attach to the Trial Handle for use in Anterior Lumbar Interbody Fusion Procedures.
The recall was initiated because the trial handles and heads may not be compatible. The devices were distributed only to the Veterans Affairs (VA) system in the United States.
Healthcare facilities that have received these devices should stop using them and contact SpineFrontier, Inc. for instructions on how to return the products.
The recalled product
- Product
- Arena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm…
- Manufacturer
- SpineFrontier, Inc.
- Hazard
- Affected units
- 23
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 (6)
- 2572401
- 2572402
- 2572405
- 05172
- 2572403
- 2572404
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by SpineFrontier, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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