Brand Name: Elegance¿ Anterior Cervical Plate Product recall
Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL…
Why was Brand Name: Elegance¿ Anterior Cervical Plate Product recalled?
Due to a quality issue regarding the presence of burr on the finished cervical plate product.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- Product
- Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL…
- Recalling firm
- Clariance-SAS
- Quantity
- 511
- Distribution
- U.S. Nationwide distribution in the states of CA, IL, NY and TX.
- Recall date
- April 22, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)