Home / Recalls / Gyrus ACMI, Inc. / Z-1187-2019

Z-1187-2019 Class II Terminated

Recalled by Gyrus ACMI, Inc. — Bartlett, TN

Recall Details

Product Type
Devices
Report Date
April 24, 2019
Initiation Date
March 8, 2019
Termination Date
May 8, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
161

Product Description

Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS

Reason for Recall

Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades

Distribution Pattern

Nationwide Foreign: Germany,Japan, Singapore

Code Information

All lot numbers

Other recalls by Gyrus ACMI, Inc.

  • Z-1179-2019 Class II — Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part (March 8, 2019)
  • Z-1184-2019 Class II — Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS (March 8, 2019)
  • Z-1185-2019 Class II — Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040 (March 8, 2019)
  • Z-1178-2019 Class II — Olympus Diego Elite Console MDCONS 100 (March 8, 2019)
  • Z-1180-2019 Class II — Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000S (March 8, 2019)
  • Z-1183-2019 Class II — Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB404 (March 8, 2019)
  • Z-1182-2019 Class II — Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040 (March 8, 2019)
  • Z-1186-2019 Class II — Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS (March 8, 2019)
  • Z-1181-2019 Class II — Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC (March 8, 2019)
  • Z-1337-2018 Class II — Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system (August 3, 2017)