SpineFrontier Recalls Arena-L Trial Handles and Heads Due to Compatibility Issues
SpineFrontier, Inc. is recalling 23 Arena-L Trial Handles and Heads because the components may not be compatible. The devices were distributed only to the U.S. Department of Veterans Affairs.
What this means for you
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, but the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a functional compatibility issue rather than a direct physical injury risk, fitting the criteria for a moderate severity score.
Plain-English summary
SpineFrontier, Inc. is recalling 23 Arena-L Trial Handles and Heads. The recall is issued because the handles and heads may not be compatible with each other. The trial heads are smooth plates made of 17-4 Stainless Steel intended to mimic the footprint of an implant, while the trial handle consists of a knurled handle and cylindrical shaft. These devices are used to distract the disc space to gauge the size of the implant needed for an Anterior Lumbar Interbody Fusion Procedure.
The affected devices were distributed only to the U.S. Department of Veterans Affairs (VA). The recall covers specific part numbers 11-81002, 11-81004-XX, and 11-81012-XX, associated with codes CT128047 and CT128048.
The source text does not specify any reported injuries, illnesses, or fatalities associated with this recall. Users should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Arena-L Trial Handle; Part: 11-81002 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 (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are
- 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 (2)
- CT128047
- CT128048
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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