# FDA recall Z-1821-2026

> **Clariance-SAS** · Class II · device recall initiated 2026-02-20.

## Product

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.

## Reason for recall

Due to a quality issue regarding the presence of burr on the finished cervical plate product.

## Distribution

U.S. Nationwide distribution in the states of CA, IL, NY and TX.

## Key facts

- **Recall number:** Z-1821-2026
- **Recalling firm:** Clariance-SAS
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-20
- **Report date:** 2026-04-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Beaurains, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1821-2026

## Citation

> AI Analytics. FDA recall Z-1821-2026. Retrieved 2026-09-08 from https://api.ai-analytics.org/recall/Z-1821-2026. Source: US FDA. Licensed CC0.

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