Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Reported: January 21, 2026 Initiated: October 29, 2025 #Z-1039-2026
Product Description
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Reason for Recall
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Details
- Recalling Firm
- Medicrea International
- Units Affected
- 44 units
- Distribution
- US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.
- Location
- Rillieux La Pape
Frequently Asked Questions
What product was recalled? ▼
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174. Recalled by Medicrea International. Units affected: 44 units.
Why was this product recalled? ▼
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 21, 2026. Severity: Moderate. Recall number: Z-1039-2026.
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