FDAHealthOctober 29, 2025
Medicrea International — Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
⚠️ 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 PL Instruments Set, Rx Only REF: SPS03174
- Lot code
- 0001
Additional details
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
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.