Bartlett, TN, United States
Gyrus ACMI, Inc. recalls
3 recalls recorded since 2018, most recently on 8 March 2019. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 8 March 2019
- Terminated
- 8 May 2020
- Reason
- Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- Distribution
- Nationwide Foreign: Germany,Japan, Singapore
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1179-2019, Z-1185-2019, Z-1184-2019, Z-1186-2019, Z-1180-2019, Z-1182-2019, Z-1183-2019, Z-1187-2019, Z-1181-2019, Z-1178-2019
- Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
- Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
- Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
- Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
- Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
- Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
- Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
- Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS
- and 2 more product lines
Terminated Class II Medical devices
- Recall started
- 17 April 2018
- Terminated
- 18 September 2023
- Reason
- There is a potential for the cord to spark and cause a fire.
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, and WY., and to the countries of :
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1952-2018
- Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end
Ongoing Class II Medical devices
- Recall started
- 3 August 2017
- Reason
- "Chattering" when cutting burrs are used in bone.
- Distribution
- NM, MI, and TX EU, Australia, Japan, and Hong Kong
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1337-2018
- Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.