Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 22, 2014
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 (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 ha
Handles and heads may not be compatible.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
SpineFrontier, Inc. recalled Arena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-… - a moderate-severity action.
Arena-L 35x26 Trial Head I 10¿ Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-… was recalled by SpineFrontier, Inc. in January 22, 2014. Reason: Handles and heads may not be compatible.. Check the official notice for the remedy. Verify recall #Z-0777-2014 with the FDA Devices before acting.
The recall
SpineFrontier, Inc. issued this moderate-severity FDA Devices recall-Handles and heads may not be compatible..
- Moderate
- severity level
- 23 units
- affected scope
- Class II
- classification
- January 22, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0777-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0777-2014) was formally reported on January 22, 2014, with the manufacturer initiating the action on September 24, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. SpineFrontier, Inc. is listed as the recalling firm, operating out of Beverly, MA. Federal records list the affected scope as 23 devices in total.
The documented reason for this recall is: Handles and heads may not be compatible. Distribution data in the federal record shows the product reached: US Distribution: VA only.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
23 devices in total
Related Recalls
6
3 from same agency
Product description
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 (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.
Reason for recall
Handles and heads may not be compatible.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0777-2014 |
| Date reported | January 22, 2014 |
| Date initiated | September 24, 2013 |
| Recalling firm | SpineFrontier, Inc. |
| Firm location | Beverly, MA |
| Affected scope | 23 devices in total |
| Distribution | US Distribution: VA only. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0777-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 (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.. Recalled by SpineFrontier, Inc.. Units affected: 23 devices in total.
Why was this product recalled? ▼
Handles and heads may not be compatible.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2014. Severity: Moderate. Recall number: Z-0777-2014.
Where was the recalled product distributed? ▼
Distribution: US Distribution: VA only..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0777-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 22, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.