Marietta, GA, US · 3 510(k) clearances · 3 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QWJ | Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament | Class II | General, Plastic Surgery | 1 | 2026-04-09 |
| OWW | — | — | — | 1 | 2023-05-26 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | 1 | 2020-09-02 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-02-06 | Class II | Ongoing | Z-1556-2026 | Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEX… | — | Augmentation devices failed bacterial endotoxin testing. |
| 2026-02-06 | Class II | Ongoing | Z-1555-2026 | Artelon FlexBand Plus Ref: 41054 & 41057 | — | Augmentation devices failed bacterial endotoxin testing. |
| 2026-02-06 | Class II | Ongoing | Z-1554-2026 | Artelon FlexBand Dynamic Matrix Ref: 31057 | — | Augmentation devices failed bacterial endotoxin testing. |