FDAFDA · Food and drugs·Recall number Z-0483-2025
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.
Published November 27, 2024 · Recall initiated: September 19, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Novosource, LLC
- Distributor
- Florida, West Virginia
- Lot
- UDI-DI 00811382037849; Lot Number CER0023
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.