Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2103-2013·Announced 2013-09-04

SpineNet Anterior Cervical Cage Recalled for Incorrect Instructions for Use

SpineNet is recalling 400 anterior cervical cages because the instructions for use contained statements that should have been removed prior to marketing.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 explicitly states the issue is with the instructions for use and does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

SpineNet is recalling 400 units of the SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage). The affected products are distributed nationwide in the United States, specifically within the state of Florida. The recall involves specific reference numbers and sizes, including CL1012-05 through CL1012-10 and CL1014-05 through CL1014-10.

The recall was initiated because it was determined that the instructions for use (IFU) contained certain statements that should have been removed prior to the initial marketing of the product. The source text does not report any illnesses, injuries, or deaths associated with this recall.

Healthcare providers and patients should contact SpineNet for further instructions regarding the return or replacement of the affected devices. The source text does not provide specific consumer action steps beyond the standard recall notification.

The recalled product

Product: SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc…
Manufacturer: SpineNet
Category: Medical Device — Orthopedic Implants
Hazard: mis-labeling
Affected units: 400

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 (12)

Ref. No. CL1012-05 Size 10mm x 12mm x 5mm
Ref. No. CL1012-06 Size 10mm x 12mm x 6mm
Ref. No. CL1012-07 Size 10mm x 12mm x 7mm
Ref. No. CL1012-08 Size 10mm x 12mm x 8mm
Ref. No. CL1012-09 Size 10mm x 12mm x 9mm
Ref. No. CL1012-10 Size 10mm x 12mm x 10mm
Ref. No. CL1014-05 Size 12mm x 14mm x 5mm
Ref. No. CL1014-06 Size 12mm x 14mm x 6mm
Ref. No. CL1014-07 Size 12mm x 14mm x 7mm
Ref. No. CL1014-08 Size 12mm x 14mm x 8mm
Ref. No. CL1014-09 Size 12mm x 14mm x 9mm
and Ref. No. CL1014-10 Size 12mm x 14mm x 10mm.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · SpineNet

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Moderate
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