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Medicrea International: Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174

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 PL Instruments Set, Rx Only REF: SPS03174
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# 0001, 0002, 0003, 0004, 0005, 0006, 0008, 0009, 0010, 0011, 0012, 0013, 0014, 0016 ,0017 ,0018, 0020, 0021, 0024, 0025, 0026, 0029/UDI: SPS03174
Product quantity
44 units
Voluntary mandated
Voluntary: Firm initiated
City
Rillieux La Pape
Country
France
Event id
97996
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