FDA-Device2026-04-22Class IIPROCESSING DEFECT
Clariance Elegance Anterior Cervical Plates recalled for manufacturing defects
OTHERNationwide distribution
Contact your surgeon about Elegance cervical plates
Clariance-SAS is recalling multiple lots of Elegance Anterior Cervical Plates (used in neck spine surgery) due to burrs found on some finished plates. The burrs are sharp edges that could cause injury during or after implantation. No injuries have been reported so far.
- If you received one of these plates as part of spine surgery, contact your surgeon or hospital immediately with your lot number
- Check any documentation from your procedure for the catalog number and lot code listed in this recall
- Your surgeon will advise whether your specific implant needs to be addressed
Hazard
Due to a quality issue regarding the presence of burr on the finished cervical plate product.
Sold states
U.S. Nationwide distribution in the states of CA, IL, NY and TX.
Affected count
511
Manufactured in
18 Rue Robespierre, N/A, Beaurains, N/A, France
Products
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 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1821-2026Don't want to check this manually?
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