Recall Z-1039-2026— Medicrea International

Name: FDA recall Z-1039-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-29

Class II · Ongoing

Class II FDA medical device recall by Medicrea International, initiated 2025-10-29. It names one FDA 510(k) clearance: K241164. 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..

Recalling firm: Medicrea International
Classification: Class II
Status: Ongoing
Initiated: 2025-10-29
Firm location: Rillieux La Pape, France

510(k) clearances named in this recall

1 on FDA's record

K241164 — IB3D PL Spinal SystemMedicrea International S.A.S. (Medtronic)·cleared 2024-09-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.