FDA Enforcement
Class II
Ongoing
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Recall: Z-1039-2026
·
Reported January 21, 2026
Enforcement
- Recall Number
- Z-1039-2026
- Event ID
- 97996
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medicrea International
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 21, 2026
- Initiation Date
- October 29, 2025
- Classification Date
- January 9, 2026
- Address
- 5389 route de Strasbourg, Vancia, Rillieux La Pape, N/A, France
Description
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.
Code Info
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
Distribution
US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.
Quantity
44 units