Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL
Summary
The FDA issued a Class II for Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CE by Clariance-SAS. Reason: Due to a quality issue regarding the presence of burr on the finished cervical plate product..
Details
Source
Device Recall
External ID
Z-1821-2026
Action Date
2026-04-22
Status
Ongoing
Category
device
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.
Lot/Code Info: Lot Code: See Excel sheet attached named "FDA 5072 Product Information" See Spreadsheet attached named "FDA 5072 Product Quantity Distributed" Catalog Number: 53430108 (ELEGANCE 1 LEVEL CERVICAL PLATE 8MM) UDI-DI code: 03700780644353 Lot Numbers: PC03X R879X Catalog Number: 53430110 (ELEGANCE 1 LEVEL CERVICAL PLATE 10MM) UDI-DI code: 03700780644353 Lot Numbers: P758X RAA2X R825X R902X Catalog Number: 53430111 (ELEGANCE 1 LEVEL CERVICAL PLATE 11MM) UDI-DI code: 03700780644384 Lot Numbers: R194X RAA1X Catalog Number: 53430112 (ELEGANCE 1 LEVEL CERVICAL PLATE 12MM) UDI-DI code: 03700780644391 Lot Numbers: R195X RAB2X Catalog Number: 53430113 (ELEGANCE 1 LEVEL CERVICAL PLATE 13MM) UDI-DI code: 03700780644407 Lot Numbers: R196X R197X R584X RA81X Catalog Number: 53430114 (ELEGANCE 1 LEVEL CERVICAL PLATE 14MM) UDI-DI code: 03700780644414 Lot Number: R585X Catalog Number: 53430116 (ELEGANCE 1 LEVEL CERVICAL PLATE 16MM) UDI-DI code: 03700780644438 Lot Number: R586X Catalog Number: 53430120 (ELEGANCE 1 LEVEL CERVICAL PLATE 20MM) UDI-DI code: 03700780644452 Lot Number: R182X Catalog Number: 53430220 (ELEGANCE 2 LEVEL CERVICAL PLATE 20MM) UDI-DI code: 03700780644452 Lot Numbers: R587X RAA0X Catalog Number: 53430224 (ELEGANCE 2 LEVEL CERVICAL PLATE 24MM) UDI-DI code: 03700780644490 Lot Number: R588X Catalog Number: 53430228 (ELEGANCE 2 LEVEL CERVICAL PLATE 28MM) UDI-DI code: 03700780644513 Lot Numbers: R589X RA80X Catalog Number: 53430230 (ELEGANCE 2 LEVEL CERVICAL PLATE 30MM) UDI-DI code: 03700780644520 Lot Numbers: R556X RA99X Catalog Number: 53430232 (ELEGANCE 2 LEVEL CERVICAL PLATE 32MM) UDI-DI code: 03700780644537 Lot Numbers: R590X RAB3X Catalog Number: 53430234 (ELEGANCE 2 LEVEL CERVICAL PLATE 34MM) UDI-DI code: 03700780644544 Lot Numbers: R591X R880X RA98X Catalog Number: 53430236 (ELEGANCE 2 LEVEL CERVICAL PLATE 36MM) UDI-DI code: 03700780644551 Lot Numbers: R592X R881X RA97X RAU3X Catalog Number: 53430240 (ELEGANCE 2 LEVEL CERVICAL PLATE 40MM) UDI-DI code: 03700780644575 Lot Numbers: R593X RA96X Catalog Number: 53430338 (ELEGANCE 3 LEVEL CERVICAL PLATE 38MM) UDI-DI code: 03700780644582 Lot Numbers: R5B7X RAV7X Catalog Number: 53430344 (ELEGANCE 3 LEVEL CERVICAL PLATE 44MM) UDI-DI code: 03700780644605 Lot Numbers: R5B2X RAY6X Catalog Number: 53430347 (ELEGANCE 3 LEVEL CERVICAL PLATE 47MM) UDI-DI code: 03700780644612 Lot Numbers: R5B3X R8H4X RA95X Catalog Number: 53430350 (ELEGANCE 3 LEVEL CERVICAL PLATE 50MM) UDI-DI code: 03700780644629 Lot Numbers: R579X RA94X Catalog Number: 53430353 (ELEGANCE 3 LEVEL CERVICAL PLATE 53MM) UDI-DI code: 03700780644636 Lot Number: R5B0X Catalog Number: 53430356 (ELEGANCE 3 LEVEL CERVICAL PLATE 56MM) UDI-DI code: 03700780644643 Lot Numbers: R5B1X R5B6X RB63X Catalog Number: 53430362 (ELEGANCE 3 LEVEL CERVICAL PLATE 62MM) UDI-DI code: 03700780644667 Lot Number: R594X
Quantity Affected: 511
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-20
Company
Beaurains, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Clariance-SAS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Clariance-SAS have FDA actions?
This is the only FDA action we have on record for Clariance-SAS in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1821-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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