Brand Name: Elegance Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PL
FDA device recall Z-1821-2026 · posted 2026-04-15 · Open, Classified
Recall details
- Recalling firm
- Clariance-SAS
- Reason for recall
- Due to a quality issue regarding the presence of burr on the finished cervical plate product.
- Action taken
- 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
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- KWQ
- Quantity affected
- 511
- Distribution
- U.S. Nationwide distribution in the states of CA, IL, NY and TX.
- Date initiated
- 2026-02-20
- Date posted
- 2026-04-15
- Location
- Beaurains, France
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Elegance® Anterior Cervical plate (K243904) | Clariance | 2025-01-14 |