FDAFebruary 20, 2026device
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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to a quality issue regarding the presence of burr on the finished cervical plate product.
What to do
FDA enforcement status: Ongoing
Brands named
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UPCs
037007806443530370078064438403700780644391037007806444070370078064441403700780644438037007806444520370078064449003700780644513037007806445200370078064453703700780644544
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPearl Milling Company Original Pancake & Waffle Mix Complete (Mezcla Para Panqueques y Waffles) Net Wt 5.99 oz (170 g). Packed in 50 - 5.99 oz BOPP Pouch units per master case. Keep in a cool, dry place.2026-05-13
- FDAEPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutane...2025-05-23
- FDAAtalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.2025-04-03
- FDAThe EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. During the planning ...2024-08-05
- FDAI.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST1802024-01-26
- FDAI.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST1752024-01-26
- FDAHIGH V+ Spinal Cement System REF T040321K2022-12-15
- FDAROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.2021-09-22
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