CLASS II ONGOING Device recall · Reported 27 Nov 2024 · FDA Enforcement Report
NovoHip Biolox Ball Head 32mmL recalled by Novosource
Novosource is recalling NovoHip Biolox Ball Head 32mmL, distributed in Florida, West Virginia. The recall was initiated on 19 Sep 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0483-2025
- FDA event ID
- 95598
- Recalling firm
- Novosource, Morgantown, WV
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Sep 2024
- FDA classified
- 18 Nov 2024
- Reported
- 27 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Hip & Knee Implants
Timeline
| 19 Sep 2024 | Recall initiated by company | |
| 18 Nov 2024 | Classified by FDA | +60 days |
| 27 Nov 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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 as listed by the FDA
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.
Where it was distributed
Florida, West Virginia
Questions about this recall
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
Which lots are affected?
UDI-DI 00811382037849; Lot Number CER0023
Where was it sold?
Florida, West Virginia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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