Z-2380-2021 Class II Terminated
FDA device recall Z-2380-2021 was initiated by Olympus Corporation of the Americas on June 9, 2021 and is designated Class II. Reason for recall: Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or electrical continui… The recall status is terminated (terminated February 17, 2023). Affected quantity: 6 boxes (5 per/box)=30 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 8, 2021
- Initiation Date
- June 9, 2021
- Termination Date
- February 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 boxes (5 per/box)=30 units
Product Description
Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC
Reason for Recall
Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or electrical continuity to patient causing tissue burn to critical structures.
Distribution Pattern
US Nationwide distribution in the states of CA, GA, MN, TN.
Code Information
Lot number KR121617