Clariance-SAS: 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

Hazard

Due to a quality issue regarding the presence of burr on the finished cervical plate product.

Details from the source

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. Quantity: 511 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

UPC codes

03700780644353, 03700780644384, 03700780644391, 03700780644407, 03700780644414, 03700780644438, 03700780644452, 03700780644490, 03700780644513, 03700780644520, 03700780644537, 03700780644544, 03700780644551, 03700780644575, 03700780644582, 03700780644605, 03700780644612, 03700780644629, 03700780644636, 03700780644643, 03700780644667

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.