Novosource, LLC: Device Recall
Recall #Z-0483-2025 · 09/19/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0483-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Novosource, LLC
- Status
- Ongoing
- Date Initiated
- 09/19/2024
- Location
- Morgantown, WV, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
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
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.
Distribution Pattern
Florida, West Virginia
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.