Salt Lake City, UT, US · 5 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | 4 | 2026-07-23 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | 1 | 2022-09-23 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-09-23 | Class II | Ongoing | Z-0432-2026 | Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 320… | — | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infectio… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-23 | K261734 | Klassic Infection Spacer System | JWH | Class II | Orthopedic |
| 2022-09-23 | K220483 | Platform® Acetabular System | LZO | Class II | Orthopedic |
| 2022-06-22 | K211877 | Klassic Knee System | JWH | Class II | Orthopedic |
| 2021-07-23 | K211602 | Klassic Knee System | JWH | Class II | Orthopedic |
| 2020-10-09 | K202740 | Klassic Knee System Tibial Inserts, PS-Max | JWH | Class II | Orthopedic |