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Medicrea International: Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000

Medical DevicesSource: FDA (device) · Date: 2026-01-21

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medicrea International
Product
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Reason / hazard
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.
Recall initiated
2025-10-29
Code info
Lot# 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, 21J1027/ UDI: (01)03613720286677
Product quantity
44 units
Voluntary mandated
Voluntary: Firm initiated
City
Rillieux La Pape
Country
France
Event id
97996
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