FDAClass IIJanuary 21, 2026

Medicrea recall

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

Why was Medicrea recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, 21J1027/ UDI: (01)03613720286677

Product
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Recalling firm
Medicrea International
Quantity
44 units
Distribution
US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.
Recall date
January 21, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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