Home / Recalls / Medicrea International / Z-1038-2026

Z-1038-2026 Class II Ongoing

Recalled by Medicrea International — Rillieux La Pape

Recall Details

Product Type
Devices
Report Date
January 21, 2026
Initiation Date
October 29, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
44 units

Product Description

Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000

Reason for Recall

Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.

Distribution Pattern

US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.

Code Information

Lot# 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, 21J1027/ UDI: (01)03613720286677

Other recalls by Medicrea International

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  • Z-2461-2023 Class II — IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B (July 12, 2023)
  • Z-2457-2023 Class II — IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d (July 12, 2023)
  • Z-2462-2023 Class II — IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) (July 12, 2023)
  • Z-2454-2023 Class II — IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar (July 12, 2023)
  • Z-2460-2023 Class II — IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B2 (July 12, 2023)