Home / Recalls / Medicrea International / Z-2460-2023

Z-2460-2023 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
0 (US)

Product Description

IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical

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) B20240104, GTIN 03613720234241, Lot Numbers: 19A0773, 19B0524, 19C0511, 19E0477, 19K0180; b) B20240105, GTIN 03613720234258, Lot Numbers: 18K0653, 18L0497, 19A0636, 19A0654, 19B0189, 19C0512, 19C0664, 19I0849, 19L0701, 20G0851, 20H0262, 20I0570, 20I0877, 21D0764; c) B20240106, GTIN 03613720234265, Lot Numbers: 18C0676R, 18C0677, 18D0172, 19E0573, 19K0687, 20B0586, 20H0263, 20J0077, 21D0148, 21J0504, 22B0181; d) B20240107, GTIN 03613720234272, Lot Numbers: 18D0174, 18L0401, 18L0498, 19D0672, 19E0087, 19G1092, 19K0478, 20B0587, 20H0264, 21H0507, 22B0485; e) B20240205, GTIN 03613720234319, Lot Numbers: 22D0384, 22G0443; f) B20240206, GTIN 03613720234326, Lot Numbers: 20H0265, 22B0182; g) B20240207, GTIN 03613720234333, Lot Numbers: 18I0761, 18J0489, 19C0513, 20A0488, 20H0266; h) B20240208, GTIN 03613720234340, Lot Numbers: 18K0298, 19D0565, 19I0617, 20C0164, 20H0267, 22A0736

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)