Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1039-2026 — Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174

U.S. FDA — Device Enforcement · France · 2025-10-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1039-2026
Date of alert
2025-10-29
Country / jurisdiction
France
Risk level
Class II
Risk type
recall
Brand
Medicrea International
Product category
device
Product type
Devices
Reported risk: Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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