Reported Apr 22, 2026 · Ongoing
Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL…
Clariance-SAS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Clariance-SAS · 18 Rue Robespierre · Beaurains, N/A · N/A
Is this the product you have?
- Brand NameElegance¿
- Anterior Cervical Plate Product Name
ELEGANCE 1 LEVEL CERVICAL PLATEELEGANCE 2 LEVEL CERVICAL PLATEELEGANCE 3 LEVEL CERVICAL PLATEELEGANCE 4 LEVEL
- CERVICAL PLATE Model/Catalog NumberSee Excel sheet attached named "FDA 5072 Product Information"
- Software VersionNot
- applicable Product DescriptionThe 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 codes and dates
24 of 24 products
Products covered by this recall Model / number Barcodes Product as published 5343010803700780644353Lot Code: See Excel sheet attached named "FDA 5072 Product Information" See Spreadsheet attached named "FDA 5072 Product Quantity Distributed" (ELEGANCE 1 LEVEL CERVICAL PLATE 8MM) UDI-DI code: 03700780644353 5343011003700780644353Lot Numbers: PC03X R879X (ELEGANCE 1 LEVEL CERVICAL PLATE 10MM) UDI-DI code: 03700780644353 5343011103700780644384Lot Numbers: P758X RAA2X R825X R902X (ELEGANCE 1 LEVEL CERVICAL PLATE 11MM) UDI-DI code: 03700780644384 5343011203700780644391Lot Numbers: R194X RAA1X (ELEGANCE 1 LEVEL CERVICAL PLATE 12MM) UDI-DI code: 03700780644391 5343011303700780644407Lot Numbers: R195X RAB2X (ELEGANCE 1 LEVEL CERVICAL PLATE 13MM) UDI-DI code: 03700780644407 5343011403700780644414Lot Numbers: R196X R197X R584X RA81X (ELEGANCE 1 LEVEL CERVICAL PLATE 14MM) UDI-DI code: 03700780644414 5343011603700780644438Lot Number: R585X (ELEGANCE 1 LEVEL CERVICAL PLATE 16MM) UDI-DI code: 03700780644438 5343012003700780644452Lot Number: R586X (ELEGANCE 1 LEVEL CERVICAL PLATE 20MM) UDI-DI code: 03700780644452 5343022003700780644452Lot Number: R182X (ELEGANCE 2 LEVEL CERVICAL PLATE 20MM) UDI-DI code: 03700780644452 5343022403700780644490Lot Numbers: R587X RAA0X (ELEGANCE 2 LEVEL CERVICAL PLATE 24MM) UDI-DI code: 03700780644490 5343022803700780644513Lot Number: R588X (ELEGANCE 2 LEVEL CERVICAL PLATE 28MM) UDI-DI code: 03700780644513 5343023003700780644520Lot Numbers: R589X RA80X (ELEGANCE 2 LEVEL CERVICAL PLATE 30MM) UDI-DI code: 03700780644520 5343023203700780644537Lot Numbers: R556X RA99X (ELEGANCE 2 LEVEL CERVICAL PLATE 32MM) UDI-DI code: 03700780644537 5343023403700780644544Lot Numbers: R590X RAB3X (ELEGANCE 2 LEVEL CERVICAL PLATE 34MM) UDI-DI code: 03700780644544 5343023603700780644551Lot Numbers: R591X R880X RA98X (ELEGANCE 2 LEVEL CERVICAL PLATE 36MM) UDI-DI code: 03700780644551 5343024003700780644575Lot Numbers: R592X R881X RA97X RAU3X (ELEGANCE 2 LEVEL CERVICAL PLATE 40MM) UDI-DI code: 03700780644575 5343033803700780644582Lot Numbers: R593X RA96X (ELEGANCE 3 LEVEL CERVICAL PLATE 38MM) UDI-DI code: 03700780644582 5343034403700780644605Lot Numbers: R5B7X RAV7X (ELEGANCE 3 LEVEL CERVICAL PLATE 44MM) UDI-DI code: 03700780644605 5343034703700780644612Lot Numbers: R5B2X RAY6X (ELEGANCE 3 LEVEL CERVICAL PLATE 47MM) UDI-DI code: 03700780644612 5343035003700780644629Lot Numbers: R5B3X R8H4X RA95X (ELEGANCE 3 LEVEL CERVICAL PLATE 50MM) UDI-DI code: 03700780644629 - Amount recalled
- 511
Where it was sold
Why it was recalled
Due to a quality issue regarding the presence of burr on the finished cervical plate product.
This product could cause temporary or reversible health problems — stop using it.
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