NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System — Class II medical device recall Z-0483-2025
Ongoing recall by Novosource, LLC, reported 2024-11-27, distributed in FL, WV. Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result
| Recall number | Z-0483-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novosource, LLC, Morgantown, WV, United States |
| Recall initiated | 2024-09-19 |
| Classified | 2024-11-18 |
| Reported by FDA | 2024-11-27 |
| Distributed | FL, WV |
| Quantity | 1 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00811382037849 |
| Lot numbers | CER0023 |
| Model numbers | 1345-2803 |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0483-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.