Reported Jan 21, 2026 · Ongoing
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Medicrea International
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: Medicrea International · 5389 route de Strasbourg · Rillieux La Pape · N/A
Is this the product you have?
- Medicrea, IB3D Universal Implant Inserter
- Rx Only REFA24000000
- Lot codes and dates
Lot# 21J041021J041421J041825A002321J046621J1027/
- UDI(01)03613720286677
- Amount recalled
- 44 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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