Device recall
Z-0483-2025: NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip…
FDA device recall · Class II · Novosource, LLC
Key facts
| Recall number (Z-number) | Z-0483-2025 |
|---|---|
| Recall event | 95598 |
| Product | NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral head, acetabular poly liner, and acetabular metal (or shell) components. |
| Product code | LPH |
| Recalling firm | Novosource, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K132158 |
| FEI number | 9989232 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database