CLASS II Device recall · Reported 22 Jan 2014 · FDA Enforcement Report
Arena-L 38x28Trial Head I 10¿ Lordotic recalled by SpineFrontier
SpineFrontier is recalling Arena-L 38x28Trial Head I 10¿ Lordotic, distributed in Virginia. The recall was initiated on 24 Sep 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0778-2014
- FDA event ID
- 66298
- Recalling firm
- SpineFrontier, Beverly, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Sep 2013
- FDA classified
- 16 Jan 2014
- Reported
- 22 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Spinal Implants
Timeline
| 24 Sep 2013 | Recall initiated by company | |
| 16 Jan 2014 | Classified by FDA | +114 days |
| 22 Jan 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Handles and heads may not be compatible.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure
Where it was distributed
US Distribution: VA only.
Questions about this recall
Is Arena-L 38x28Trial Head I 10¿ Lordotic recalled?
Yes. SpineFrontier recalled Arena-L 38x28Trial Head I 10¿ Lordotic on 24 Sep 2013. The recall is Class II and its status is Terminated. Recall number Z-0778-2014.
Why was it recalled?
Handles and heads may not be compatible.
Which lots are affected?
05171, 2572501, 2572502, 2572503
Where was it sold?
US Distribution: VA only.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
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| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
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