Recall Z-0146-2022 ยท HRX Arthroscope
ADRIA SRL
Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749
| Date | May 17, 2021 |
| Status | Terminated |
| 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 |
| Distribution | The products were distributed to the following US states: NJ and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141557 | HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR Gallini Medical Devices, Srl, Dec 8, 2014 |