Class II — Novosource, LLC
| Recalling firm | NovoSource LLC |
|---|---|
| Registered facility | NOVOSOURCE, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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 |
| 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. |
| Quantity | 1 unit |
| Distribution | Florida, West Virginia |
| Initiated | 2024-09-19 |
| Classified | 2024-11-18 |
| Recall number | Z-0483-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Novosource, LLC (Z-0483-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95598/
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