Home / Recalls / Medtronic Xomed, Inc. / Z-2673-2020

Z-2673-2020 Class II Terminated

Recalled by Medtronic Xomed, Inc. — Jacksonville, FL

FDA device recall Z-2673-2020 was initiated by Medtronic Xomed, Inc. on June 12, 2020 and is designated Class II. Reason for recall: During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the set value in the cos… The recall status is terminated (terminated April 20, 2023). Affected quantity: 673 units.

Recall Details

Product Type
Devices
Report Date
July 29, 2020
Initiation Date
June 12, 2020
Termination Date
April 20, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
673 units

Product Description

Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures.

Reason for Recall

During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the set value in the cosole.

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of AL, AK, AZ, AR, CA,CO, CT, FL, GA, HI, ID,IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, PA, RI, SC, TN, TX, UT, VA, WV, WA, WI. The countries of Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Greece, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Poland, Singapore, Spain, Sweden, Switzerland, United Kingdom.

Code Information

Model: 1898072 Affected Lot Numbers: 0217355465, 0218377490, 0218687535, 0218928638, 0219310085,0219639840, 0217856852, 0218472653, 0218714701, 0218958034, 0219443322,0219639842, 0217858947,0218472654, 0218721203, 0218958035, 0219448447, 0219639844, 0217859045,0218665536, 0218745073, 0219004569,0219465587, 0218203285, 0218666231, 0218746389,0219201122,0219518520,0218263964, 0218666243, 0218864105, 0219255151, 0219550550, 0218293282, 0218687534, 0218900337,0219281168, 0219619754.

Other recalls by Medtronic Xomed, Inc.

  • Z-2461-2025 Class II — IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. Th (July 17, 2025)
  • Z-1623-2025 Class II — NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; (March 10, 2025)
  • Z-3130-2024 Class II — Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069 (July 5, 2024)
  • Z-2409-2024 Class I — NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vi (June 24, 2024)
  • Z-0696-2024 Class II — NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 822970 (November 7, 2023)
  • Z-1223-2022 Class II — NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2 (May 3, 2022)
  • Z-1224-2022 Class II — NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2 (May 3, 2022)
  • Z-1520-2022 Class I — NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) RE (April 29, 2022)
  • Z-1519-2022 Class I — NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 (April 29, 2022)
  • Z-1521-2022 Class I — NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) (April 29, 2022)

FDA data resources