Home / Recalls / Medicrea International / Z-2453-2023

Z-2453-2023 Class II Ongoing

Recalled by Medicrea International — Rillieux La Pape, N/A

Recall Details

Product Type
Devices
Report Date
August 30, 2023
Initiation Date
July 12, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11 units

Product Description

IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar

Reason for Recall

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Distribution Pattern

US nationwide

Code Information

a) B15111209, GTIN 03613720193395, Lot Numbers: 19C0772; b) B15111212, GTIN 03613720193401, Lot Numbers: 19C0775, 19G0070; c) B15111409, GTIN 03613720193425, Lot Numbers: 19E0353; d) B15111412, GTIN 03613720193432, Lot Numbers: 19C0788

Other recalls by Medicrea International

  • Z-1038-2026 Class II — Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000 (October 29, 2025)
  • Z-1039-2026 Class II — Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174 (October 29, 2025)
  • Z-1118-2025 Class II — UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 U (December 3, 2024)
  • Z-2456-2023 Class II — IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) (July 12, 2023)
  • Z-2458-2023 Class II — PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B (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-2461-2023 Class II — IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B (July 12, 2023)
  • Z-2459-2023 Class II — GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A131 (July 12, 2023)
  • Z-2457-2023 Class II — IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d (July 12, 2023)