Recall Z-2356-2026
- Recall number
- Z-2356-2026
- Event number
- 98823
- Firm
- Sagemax Bioceramics, Inc.
- Firm FEI
- 3007518500
- Product code
- EIH
- Status
- Open, Classified
- Initiated
- 2025-12-11
- Posted
- 2026-06-09
- Root cause
- Process control
- 510(k) numbers
- K142233, K070772, K915653, K231687, K233016, K214003, K022996, K212259, K940252, K213722, K102128, K202629, K203499, K221429, K993897, K223253, K183304, K011333, K050903, K111383, K000983, K033221, K093748, K214005, K970941, K040421, K152451, K921619, K082158, K250811
Product#
NexxZr T Multi A3.5 W98-16mm, REF: 745451
Reason for Recall#
Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress.