FDA Device recall Z-0483-2025
NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that con…
- FDA Device
- Class II
- ongoing
- Published 2024-11-27
On 2024-11-27 the FDA classified a Class II recall of NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that con… by Novosource, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0483-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-19 |
| Published | 2024-11-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Novosource |
| Distribution | FL, WV |
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.
Reason
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
Identifiers
| code_info | UDI-DI 00811382037849; Lot Number CER0023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0483-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.