FDAClass IIOctober 27, 2021

Herniatome recall

Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749

Why was Herniatome recalled?

The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.

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: AD0063/20 AD0313/20 AD0302/20

Product
Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749
Recalling firm
ADRIA SRL
Quantity
N/A
Distribution
The products were distributed to the following US states: NJ and NY.
Recall date
October 27, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls