Home / Recalls / Gyrus ACMI, Inc. / Z-1337-2018

Z-1337-2018 Class II Ongoing

Recalled by Gyrus ACMI, Inc. — Bartlett, TN

Recall Details

Product Type
Devices
Report Date
April 18, 2018
Initiation Date
August 3, 2017
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
324

Product Description

Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system

Reason for Recall

"Chattering" when cutting burrs are used in bone.

Distribution Pattern

NM, MI, and TX EU, Australia, Japan, and Hong Kong

Code Information

Catalog No. (UDI-DI): MBUR5060FRCV (00821925036529), MBUR6060FRCV (00821925036536), and MBUR7060FRCV (00821925036543) ALL LOTS MANUFACTURED BEFORE AUGUST 3, 2017

Other recalls by Gyrus ACMI, Inc.

  • 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-1187-2019 Class II — Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS (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-1179-2019 Class II — Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part (March 8, 2019)