Gyrus Acmi PKS Omni 5mm/33cm-intended for the recall: Foreign Material
Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of…
Why was Gyrus Acmi PKS Omni 5mm/33cm-intended for the recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot number KR121617
- Product
- Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 6 boxes (5 per/box)=30 units
- Distribution
- US Nationwide distribution in the states of CA, GA, MN, TN.
- Recall date
- September 8, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)