What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

FDA Recall Database: Class II Recall: Brand Name: Elegance¿ Anterior Cervical Plate Product Name:… by Clariance-SAS

At a glance: Clariance-SAS recalled Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" (additional items listed in FDA's full record) on 2026-04-22. FDA classified this action as a Class II recall (recall number Z-1821-2026). Reason for recall: Due to a quality issue regarding the presence of burr on the finished cervical plate product.. Recall status: Ongoing. This is a device-category FDA recall record.

Key facts

Recalling firm	Clariance-SAS
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not applicable Product Description: The Elegance¿Anterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance¿ Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw s holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are selfdrilling or self- tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Elegance¿plates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy. It is essential to insert the implants with the instrumentation specifically designed for this purpose. For more description of the instrumentation, read the technical documentation associated to the Elegance¿ Anterior Cervical plate. Detailed information concerning the surgical technique of the Elegance¿Anterior Cervical plate is available upon request, please contact CLARIANCE or its local representative.
Classification	Class II
Recall number	Z-1821-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Due to a quality issue regarding the presence of burr on the finished cervical plate product.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Clariance-SAS and the affected product is described in FDA's record as: Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" (additional items listed in FDA's full record). FDA's stated reason for the recall is: Due to a quality issue regarding the presence of burr on the finished cervical plate product.. The recall is tracked under FDA recall number Z-1821-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" (additional items listed in FDA's full record) -- and the recall number Z-1821-2026. If it matches, stop using or distributing it and contact Clariance-SAS or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

Clariance-SAS’s FDA history

Argus HQ has recorded 1 total FDA action tied to Clariance-SAS: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the FDA recall number for this event?: FDA recall number Z-1821-2026.
What is the current status of this recall?: Status as recorded by FDA: Ongoing.
Where can I verify this recall directly with FDA?: The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
What was recalled and why?: Clariance-SAS recalled Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" (additional items listed in FDA's full record). FDA's record states the reason for recall as: Due to a quality issue regarding the presence of burr on the finished cervical plate product.. The recall is logged under FDA recall number Z-1821-2026 with a Class.

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Full FDA history for Clariance-SAS

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Recall Database: Class II Recall: Brand Name: Elegance¿ Anterior Cervical Plate Product Name:… by Clariance-SAS. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-clariance-sas-z-1821-2026

MLA

"FDA Recall Database: Class II Recall: Brand Name: Elegance¿ Anterior Cervical Plate Product Name:… by Clariance-SAS." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-clariance-sas-z-1821-2026.

Chicago

Argus HQ Research. "FDA Recall Database: Class II Recall: Brand Name: Elegance¿ Anterior Cervical Plate Product Name:… by Clariance-SAS." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-clariance-sas-z-1821-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_clariance_sas_z_1821_2026_2026,
  title = {FDA Recall Database: Class II Recall: Brand Name: Elegance¿ Anterior Cervical Plate Product Name:… by Clariance-SAS},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-clariance-sas-z-1821-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗