Reported Nov 27, 2024 · Ongoing
NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip…
Novosource, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Novosource, LLC · 2000 Hampton Ctr Ste C · Morgantown, WV · 26505-1704
Is this the product you have?
- NovoHip Biolox Ball Head 32mmL Ref1345-2803 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
- Lot codes and dates
UDI-DI 00811382037849Lot Number CER0023
- Amount recalled
- 1 unit
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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