CLASS II ONGOING Device recall · Reported 22 Apr 2026 · FDA Enforcement Report
Elegance¿ Anterior Cervical Plate Elegance 1 Level recalled
Clariance-SAS is recalling Elegance¿ Anterior Cervical Plate Elegance 1 Level Cervical Plate, Elegance 2 Level, distributed nationwide in the US. The recall was initiated on 20 Feb 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1821-2026
- FDA event ID
- 98442
- Recalling firm
- Clariance-SAS, Beaurains, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Feb 2026
- FDA classified
- 15 Apr 2026
- Reported
- 22 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Spinal Implants
Timeline
| 20 Feb 2026 | Recall initiated by company | |
| 15 Apr 2026 | Classified by FDA | +54 days |
| 22 Apr 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a quality issue regarding the presence of burr on the finished cervical plate product.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the 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" 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.
Where it was distributed
U.S. Nationwide distribution in the states of CA, IL, NY and TX.
Questions about this recall
Why was it recalled?
Due to a quality issue regarding the presence of burr on the finished cervical plate product.
Which lots are affected?
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
Where was it sold?
U.S. Nationwide distribution in the states of CA, IL, NY and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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