FDA Medical Device Recalls (openFDA)
ADRIA SRL: Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749
- Recall number
- Z-0146-2022
- Recalling firm
- ADRIA SRL
- Product
- Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749
- Status
- Terminated
- Initiated
- 2021-05-17
- Posted
- not on file
- Terminated
- 2023-11-06
- Reason
- The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed.
- Root cause
- 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
- Quantity
- not on file
- Distribution
- The products were distributed to the following US states: NJ and NY.
- Lot, serial or model codes
- Lot Number: AD0063/20 AD0313/20 AD0302/20
- 510(k) numbers
- ["K141557"]
- PMA numbers
- not on file
- Product code
- HRX
- Firm FEI
- 3014200871
- Firm city
- San Giovanni In Persiceto
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28