FDA Medical devices recall ·
Medicrea, IB3D PL Instruments Set, Rx Only recall
- Recall number
- Z-1039-2026
- Date
- (initiated October 29, 2025)
- Company / brand
- Medicrea International
5389 route de Strasbourg, Rillieux La Pape, France - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 44 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Why was it recalled?
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: California Florida Minnesota North Carolina Ohio Rhode Island Tennessee Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1039-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.