Recall of Elegance Anterior Cervical Plates by Clariance-SAS

Source: FDA · United States

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Clariance-SAS is recalling 511 units of Elegance Anterior Cervical Plates due to a quality issue with burrs on the products, affecting distribution in California, Illinois, New York, and Texas.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 3, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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Recall of Elegance Anterior Cervical Plates

What Happened

Clariance-SAS is recalling the Elegance Anterior Cervical Plates due to a quality issue regarding the presence of burr on the finished product.

Which Products Are Affected

The affected products include various models such as ELEGANCE 1 LEVEL CERVICAL PLATE (catalog numbers: 53430108, 53430110, 53430111, 53430112, 53430113, 53430114, 53430116, 53430120), ELEGANCE 2 LEVEL CERVICAL PLATE (catalog numbers: 53430220, 53430224, 53430228, 53430230, 53430232, 53430234, 53430236, 53430240), and ELEGANCE 3 LEVEL CERVICAL PLATE (catalog numbers: 53430338, 53430344, 53430347, 53430350, 53430353, 53430356, 53430362). Each has specific UDI-DI codes and lot numbers as detailed in the FDA documents. A total of 511 units are affected, distributed in the states of CA, IL, NY, and TX. The official recall number is Z-1821-2026.

What You Should Do

Consumers should contact the recalling firm, Clariance-SAS, for instructions on returns or refunds, as the recall was initiated via letter.

Why This Matters

This recall involves medical devices that could pose a risk due to quality defects, potentially affecting patient safety during use.

Source

Information from the FDA recall notice, recall number Z-1821-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Clariance-SAS is recalling 511 units of Elegance Anterior Cervical Plates due to a quality issue with burrs on the products, affecting distribution in California, Illinois, New York, and Texas.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.