---
title: "NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - Novo... — FDA record Z-0483-2025 | Is It on Recall"
description: "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"
url: https://isitonrecall.com/recall/fda-device-z-0483-2025-novohip-biolox-ball-head-32mml-ref-1345-2803-novohip-total-hip-system-novohip-total-hip-system-is-a/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented h... — FDA record Z-0483-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 19, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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
- **Classification**: Class II
- **Recalling firm**: Novosource, LLC
- **Quantity**: 1 unit
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0483-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0483-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI 00811382037849; Lot Number CER0023 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Florida, West Virginia

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Florida](https://isitonrecall.com/state/florida/)
- [West Virginia](https://isitonrecall.com/state/west-virginia/)

## Dates in the source

- **Report date**: Nov 27, 2024
- **Recall initiation date**: Sep 19, 2024
- **Center classification date**: Nov 18, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0483-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Novosource, LLC records](https://isitonrecall.com/brand/novosource-llc/)