Recall Z-1821-2026 · KWQ Appliance, Fixation, Spinal Intervertebral Body
Clariance-SAS
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 pl
| Date | Apr 15, 2026 (initiated Feb 20, 2026) |
| Status | Open, Classified |
| Reason | Due to a quality issue regarding the presence of burr on the finished cervical plate product. |
| Root 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, |
| Quantity | 511 |
| Distribution | U.S. Nationwide distribution in the states of CA, IL, NY and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K243904 | Elegance® Anterior Cervical plate Clariance, Jan 14, 2025 |