SpineFrontier Recalls Arena-L Trial Heads Due to Compatibility Issues
SpineFrontier, Inc. is recalling 23 Arena-L trial heads because they may not be compatible with the trial handles.
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. The hazard is a compatibility issue between surgical trial components, which is a functional defect rather than a direct safety hazard like a high-risk pathogen or structural failure. No injuries or illnesses are reported in the source text.
Plain-English summary
SpineFrontier, Inc. is recalling 23 units of the Arena-L 38x28 Trial Head I 10° Lordotic. The affected devices are smooth plates made of 17-4 Stainless Steel, intended to be attached to a Trial Handle and inserted into the intervertebral disc space during an Anterior Lumbar Interbody Fusion Procedure. The recall is being conducted because the trial handles and heads may not be compatible.
The recall covers specific part numbers: 11-81012-08, 11-81012-10, 11-81012-12, and 11-81012-14. The source text indicates that the distribution was limited to the VA only. No specific dates, lot numbers, or additional distribution details are provided in the source text.
Healthcare providers and facilities that may have received these devices should contact SpineFrontier, Inc. for instructions on how to return or dispose of the recalled products. The source text does not specify a particular action for consumers, as these are surgical trial devices used by medical professionals.
The recalled product
- Product
- Arena-L 38x28Trial Head I 10¿ Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12, 11-81012-14 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, ea
- 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 (4)
- 05171
- 2572501
- 2572502
- 2572503
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.
See all 3 products in this recall →Related recalls
Same manufacturer · SpineFrontier, Inc.
See all →- HighSpineFrontier Recalls A-CIFT SoloFuse Fixed Angle Driver Due to Binding Risk
FDA (Devices) · 2019-07-24
- ModerateSpineFrontier Recalls MISquito Pedicle Screw System Surgical Technique Document
FDA (Devices) · 2015-04-29
- HighSpineFrontier Recalls Inline Persuader Pedicle Screw System Due to Handle Crack
FDA (Devices) · 2015-01-21
- SevereSpineFrontier S-Lift Lock Shaft Inserter Recalled for Potential Breakage
FDA (Devices) · 2014-05-14
- ModerateSpineFrontier Recalls Arena-L Trial Handles and Heads Due to Compatibility Issues
FDA (Devices) · 2014-01-22
Same hazard · incompatibility
See all →- ModerateZimmer Biomet Ceramic Hip Head 22.2 mm Lacks Stem Compatibility Information
FDA (Devices) · 2025-04-30
- ModerateZimmer Biomet Ceramic Hip Prosthesis Heads Lack Stem Compatibility Information
FDA (Devices) · 2025-04-30
- HighAMT Mini Enteral Extension Set Recalled for Incorrect Connector Type
FDA (Devices) · 2025-01-15
- HighPerfusor Space infusion pump syringe incompatibility may cause dosing error
FDA (Devices) · 2024-07-31
- HighINOmax DSIR Delivery System incompatible with upgraded Leoni Plus ventilator
FDA (Devices) · 2022-09-21