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

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on January 22, 2014. Severity: Moderate. Recall number: Z-0777-2014.

Q: Where was the recalled product distributed?

Distribution: US Distribution: VA only..

Q: 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.

Handles and heads may not be compatible.

Recall #: Z-0777-2014
Affected scope: 23 devices in total
Initiated: September 24, 2013

Compiled from official public sources by the publisher. · Updated September 2026

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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 recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

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

Structured summary of the FDA Devices recall record
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.

Scale of Impact

23 devices in total units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

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? ▼

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..

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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported January 22, 2014. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026