Clariance Elegance Anterior Cervical Plate Recall - 511 Units, Burr Defect
Summary
FDA classified a Class II recall of Clariance SAS Elegance Anterior Cervical Plate systems. The firm initiated the recall on February 20, 2026, after identifying a burr defect on finished cervical plate products. 511 units were distributed nationwide in California, Illinois, New York, and Texas. Customers are instructed to stop using affected devices, quarantine them, and return consigned stock.
What changed
FDA classified a Class II medical device recall for Clariance SAS Elegance Anterior Cervical Plate systems, comprising 511 units distributed across CA, IL, NY, and TX. The recall was initiated due to a quality issue involving burrs on finished cervical plate products, caused by process change control deficiencies. Affected catalog numbers include various 1-level through 3-level cervical plates (8MM to 62MM).
Healthcare providers and distributors in possession of these devices must immediately cease use, quarantine all affected units, and return consigned stock to Clariance. Customers must acknowledge receipt of the recall notification before February 28, 2026. Contact corp.quality@clariance-spinevision.com for questions.
What to do next
- Stop using affected devices and quarantine in facilities
- Return consigned stocks to Clariance
- Return acknowledgement of receipt before February 28, 2026
Archived snapshot
Apr 17, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Class 2 Device Recall Elegance Anterior Cervical Plate
- Databases
| 510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards |
| CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | |
| New Search | ) |
| | Class 2 Device Recall Elegance Anterior Cervical Plate | |
| Date Initiated by Firm | February 20, 2026 |
|---|---|
| Date Posted | April 15, 2026 |
| Recall Status | Open , Classified |
| Recall Number | Z-1821-2026 |
| Recall Event ID | 98442 |
| 510(K)Number | K243904 |
| Product Classification | Appliance, fixation, spinal intervertebral body - Product Code KWQ |
| 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"
Software Version: Not applicable Product Description: The EleganceAnterior 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 Eleganceplates, 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 EleganceAnterior Cervical plate is available upon request, please contact CLARIANCE or its local representative. |
| Code Information | 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: 03700780644575
Lot Numbers:
R593X
RA96X
Catalog Number: 53430338 (ELEGANCE 3 LEVEL CERVICAL PLATE 38MM)
UDI-DI code: 03700780644582
Lot Numbers:
R5B7X
RAV7X
Catalog Number: 53430344 (ELEGANCE 3 LEVEL CERVICAL PLATE 44MM)
UDI-DI code: 03700780644605
Lot Numbers:
R5B2X
RAY6X
Catalog Number: 53430347 (ELEGANCE 3 LEVEL CERVICAL PLATE 47MM)
UDI-DI code: 03700780644612
Lot Numbers:
R5B3X
R8H4X
RA95X
Catalog Number: 53430350 (ELEGANCE 3 LEVEL CERVICAL PLATE 50MM)
UDI-DI code: 03700780644629
Lot Numbers:
R579X
RA94X
Catalog Number: 53430353 (ELEGANCE 3 LEVEL CERVICAL PLATE 53MM)
UDI-DI code: 03700780644636
Lot Number:
R5B0X
Catalog Number: 53430356 (ELEGANCE 3 LEVEL CERVICAL PLATE 56MM)
UDI-DI code: 03700780644643
Lot Numbers:
R5B1X
R5B6X
RB63X
Catalog Number: 53430362 (ELEGANCE 3 LEVEL CERVICAL PLATE 62MM)
UDI-DI code: 03700780644667
Lot Number:
R594X |
| FEI Number | 3008992889 |
| Recalling Firm/
Manufacturer | Clariance-SAS
18 Rue Robespierre
Beaurains France |
| For Additional Information Contact | Quang TRAN
+33321161215 |
| Manufacturer Reason
for Recall | Due to a quality issue regarding the presence of burr on the finished cervical plate product. |
| FDA Determined
Cause | Process change control |
| Action | On 02/20/2026, the firm sent via email/videoconference/telephone call an "URGENT: MEDICAL DEVICE REMOVAL" Letter to customers informing them that, on 3 February, 2026, Clariance SAS was made aware of a quality issue regarding the presence of burr on finished products belonging to Elegance plates product range.
Customers are instructed to:
-Stop using the affected devices and put in quarantine in their facilities the Elegance plates concerned by the removal.
-For devices consignment: return the consigned stocks.
-Refer to appendix A to return the acknowledgement of receipt before February 28, 2026.
-For questions regarding this removal communication, please contact us at the following address : corp.quality@clariance-spinevision.com |
| Quantity in Commerce | 511 |
| Distribution | U.S. Nationwide distribution in the states of CA, IL, NY and TX. |
| Total Product Life Cycle | TPLC Device Report |
| 1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes. | |
| 510(K) Database | 510(K)s with Product Code = KWQ |
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