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U.S. Department of Health and Human Services

Class 2 Device Recall Herniatome

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  Class 2 Device Recall Herniatome see related information
Date Initiated by Firm May 17, 2021
Create Date October 19, 2021
Recall Status1 Terminated 3 on November 06, 2023
Recall Number Z-0146-2022
Recall Event ID 88543
510(K)Number K141557  
Product Classification Arthroscope - Product Code HRX
Product Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749
Code Information Lot Number: AD0063/20 AD0313/20 AD0302/20
Recalling Firm/
Manufacturer		 ADRIA SRL
Via Modena 46
Societa Unipersonale
San Giovanni In Persiceto Italy
Manufacturer Reason
for Recall		 The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
FDA Determined
Cause 2		 Other
Action An Urgent Field Safety Notice dated 5/17/21 was sent to customers. Actions required to distributors and economic operators 1. Immediately suspend deliveries, identify and quarantine all the devices in your possession which are listed in Annex no. 1 "List of Impacted batches". 2. Share this Field Safety Notice within your organization with all interested parties. If you have distributed the products covered by this FSN to third parties, identify these subjects and forward this letter to them immediately, communicating to each hospital the detailed list of the goods subject to this action that have been supplied by you, using the template of the Annex no. 2 "Letter of the Distributor to Hospitals" Table A1 (making sure to fill in Table A1 with the detail of the article codes and the lots destined for that hospital). 3.Fill in and sign the attached Annex no. 3 "Acknowledgment of the distributor" specifying the quantity of the quarantined goods, including their lot number, their code and inform Adria Srl by sending an email to qa@adriamedical.com and xport@adriamedical.com as soon as possible / within 10 days of receipt of this letter. 4.Adria Srl will contact you to organize the collection of the goods. Adria Srl will replace the goods as soon as possible. Actions required of hospitals and healthcare facilities 1. Identify and immediately stop using the concerned products. Place in quarantine all items listed in Table A1 that are still present at your facilities. 2.Fill in and sign the attached Annex no. 4 Acknowledgement of hospitals and health facilities specifying the quantity of the goods placed in quarantine, including their lot number, their code and inform your dealer and Adria Srl by sending an email to qa@adriamedical.com and export@adriamedical.com as soon as possible and in any case within 10 days of receipt of this letter. 3. Wait for information from Adria Srl for the actions regarding the concerned devices. Corrective Actions in place Adria Srl ha
Distribution The products were distributed to the following US states: NJ and NY.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HRX and Original Applicant = GALLINI MEDICAL DEVICES, SRL
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