Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE… — Class II medical device recall Z-1821-2026
Ongoing recall by Clariance-SAS, reported 2026-04-22, distributed nationwide. Due to a quality issue regarding the presence of burr on the finished cervical plate product.
| Recall number | Z-1821-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Clariance-SAS, Beaurains, N/A, France |
| Recall initiated | 2026-02-20 |
| Classified | 2026-04-15 |
| Reported by FDA | 2026-04-22 |
| Distributed | Nationwide (US) |
| Quantity | 511 |
| UPC / GTIN / UDI-DI | 03700780644353, 03700780644384, 03700780644391, 03700780644407, 03700780644414, 03700780644438, 03700780644452, 03700780644490, 03700780644513, 03700780644520, 03700780644537, 03700780644544, 03700780644551, 03700780644575, 03700780644582, 03700780644605, 03700780644612, 03700780644629, 03700780644636, 03700780644643, 03700780644667 |
| Lot numbers | P758X, PC03X, R182X, R194X, R195X, R196X, R197X, R556X, R579X, R584X, R585X, R586X, R587X, R588X, R589X, R590X, R591X, R592X, R593X, R594X, R5B0X, R5B1X, R5B2X, R5B3X, R5B6X, R5B7X, R825X, R879X, R880X, R881X, R8H4X, R902X, RA80X, RA81X, RA94X, RA95X, RA96X, RA97X, RA98X, RA99X and 9 more |
| Model numbers | 53430108, 53430110, 53430111, 53430112, 53430113, 53430114, 53430116, 53430120, 53430220, 53430224, 53430228, 53430230, 53430232, 53430234, 53430236, 53430240, 53430338, 53430344, 53430347, 53430350, 53430353, 53430356, 53430362 |
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. 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.
Reason for recall
Due to a quality issue regarding the presence of burr on the finished cervical plate product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1821-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.