Elegance anterior cervical plates recalled over burrs on finished product
Elegance Anterior Cervical Plates are being recalled over a quality issue involving the presence of burrs on the finished plate. The action covers 511 units.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a spinal implant with a finishing defect, a risk of harm with no injuries reported in the source.
Plain-English summary
Elegance Anterior Cervical Plates, covering the 1, 2, 3 and 4 level cervical plate products, are being recalled. The action covers 511 units. Model, catalog and lot codes are listed in the product information attached to the recall notice.
The recall is due to a quality issue regarding the presence of a burr on the finished cervical plate product. A burr is a raised edge left after machining, and its presence on an implant is a departure from the finished specification. The FDA classified the action as Class II.
Distribution was within the United States, in California, Illinois, New York and Texas. The plates are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the catalog and lot codes in the recall notice, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- 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"…
- Manufacturer
- Clariance-SAS
- Category
- Medical Device — Spinal implant
- Affected units
- 511
Distribution
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