United StatesElegance Anterior Cervical Plates (ELEGANCE 1‑, 2‑, 3‑ and 4‑LEVEL CERVICAL PLATE) distributed by Clariance‑SAS are affected; specific catalog numbers and lot codes are listed in the FDA “FDA 5072 Product Information/Quantity Distributed” spreadsheets. The recall was initiated because a quality issue was found involving the presence of burrs on finished cervical plate products. These devices were distributed nationwide in the U.S., including CA, IL, NY and TX, totaling 511 units.
What's being recalled
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…
Recalling firm: Clariance-SAS, Beaurains, N/A, France.
How to identify it
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…
The hazard
Due to a quality issue regarding the presence of burr on the finished cervical plate product.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide distribution in the states of CA, IL, NY and TX.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)