Novosource, LLC: Medical Device Recall in 2024 - (Recall #: Z-0483-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 19, 2024

Date Posted: November 27, 2024

Recall Number: Z-0483-2025

Event ID: 95598

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

Status: Ongoing

Product Quantity: 1 unit

Code Information:

UDI-DI 00811382037849; Lot Number CER0023

Distribution Pattern:

Florida, West Virginia

Voluntary or Mandated:

Voluntary: Firm initiated