Z-0483-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2024
- Initiation Date
- September 19, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
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.
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
Distribution Pattern
Florida, West Virginia
Code Information
UDI-DI 00811382037849; Lot Number CER0023