Device 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.
Z-0483-2025
Product summary
- Firm
- Novosource, LLC
- Event
- Event 95598
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0483-2025
Official wording
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
Code information: UDI-DI 00811382037849; Lot Number CER0023
Distribution pattern: Florida, West Virginia
Derived failure modes
-
Labeling or packaging
Mislabeled