Home / Recalls / Medicrea International / Z-0828-2020

Z-0828-2020 Class II Ongoing

Recalled by Medicrea International — Rillieux La Pape

Recall Details

Product Type
Devices
Report Date
January 29, 2020
Initiation Date
September 16, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
190 units

Product Description

Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140

Reason for Recall

Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded

Distribution Pattern

Nationwide

Code Information

Lot number(s) : 18G0368; 19H0009; 18F0138; 18G0038

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-2458-2023 Class II — PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B (July 12, 2023)
  • Z-2452-2023 Class II — IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122 (July 12, 2023)
  • Z-2454-2023 Class II — IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar (July 12, 2023)
  • Z-2462-2023 Class II — IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) (July 12, 2023)
  • Z-2459-2023 Class II — GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A131 (July 12, 2023)
  • Z-2461-2023 Class II — IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B (July 12, 2023)
  • Z-2456-2023 Class II — IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) (July 12, 2023)