Summary
The FDA issued a Class II for Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745 by ADRIA SRL. Reason: The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed..
Details
Source
Device Recall
External ID
Z-0145-2022
Action Date
2021-10-27
Status
Terminated
Category
device
Product Description
Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745
Lot/Code Info: Lot Number: ZV0994 AD0314/20 AD0316/20
Quantity Affected: N/A
Reason for Recall
The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
Distribution
The products were distributed to the following US states: NJ and NY.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-17
Company
San Giovanni In Persiceto, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ADRIA SRL has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ADRIA SRL) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ADRIA SRL have FDA actions?
ADRIA SRL has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0145-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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