FDAHealthOctober 29, 2025
Medicrea International — Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
⚠️ Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 29, 2025
US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.
What's affected?
- Product
- Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
- Lot code
- 21J0410
Additional details
Lot# 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, 21J1027/ UDI: (01)03613720286677
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 44 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.