Medicrea International recalls Medicrea
- Recalling company
- Medicrea International
- Product
- Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
- Reason
- Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 29, 2025
- Reported
- Jan 21, 2026
- Distribution
- US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.
- Status
- Ongoing
- Quantity
- 44 units
- Lot / codes
- 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
- Company location
- Rillieux La Pape
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1039-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1039-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.