Novosource product recalled over labeling errors

Recall date

September 19, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Novosource, LLC recalls NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip…

Recall number

Z-0483-2025

FDA classification

Class II

Brand / firm

Novosource, LLC

Sold / distributed

Florida, West Virginia

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.