WhichRecall
Class IIReported 2026-01-21

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

Recalled by Medicrea International

Reason for Recall

Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.

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Recall Number
Z-1038-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-10-29
Reported
2026-01-21
Distribution
US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.
Code Info
Lot# 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, 21J1027/ UDI: (01)03613720286677
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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