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RecallWatchMedical Device Safety
Class IIOngoingZ-1821-2026

Clariance-SAS recalls Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL…

Clariance-SASBeaurains, FranceReported Apr 22, 2026 · 2 months ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI-DI codeCatalog # Number
    97 affected lots
    507250725343010803700780644353PC03XR879X5343011003700780644353
    +89 more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

What the firm is doing

On 02/20/2026, the firm sent via email/videoconference/telephone call an "URGENT: MEDICAL DEVICE REMOVAL" Letter to customers informing them that, on 3 February, 2026, Clariance SAS was made aware of a quality issue regarding the presence of burr on finished products belonging to Elegance plates product range. Customers are instructed to: -Stop using the affected devices and put in quarantine in their facilities the Elegance plates concerned by the removal. -For devices consignment: return the consigned stocks. -Refer to appendix A to return the acknowledgement of receipt before February 28, 2026. -For questions regarding this removal communication, please contact us at the following address : corp.quality@clariance-spinevision.com

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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