FDA Medical devices recall ·
NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System -… recall
- Recall number
- Z-0483-2025
- Date
- (initiated September 19, 2024)
- Company / brand
- Novosource, LLC
2000 Hampton Ctr Ste C, Morgantown, WV, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1 unit
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI 00811382037849; Lot Number CER0023
Distribution
Florida, West Virginia
States: Florida West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0483-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.