Morgantown, WV, US · 1 510(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 | 1 | 2026-04-27 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-09-19 | Class II | Ongoing | Z-0483-2025 | NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented … | — | Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted |