Recall Z-1844-2021 ยท GEX Powered Laser Surgical Instrument
Quanta System, S.p.A.
Quanta System Sterile Optical Laser Fiber, reusable
| Date | Apr 27, 2021 |
| Status | Terminated |
| Reason | Product sterility is potentially compromised. |
| Root cause | Process control |
| Action | The recalling firm is sending recall notification letters to its consignees for further dissemination to the user level. Consignees are asked to cease use of impacted product, quarantine impacted goods and dispose of goods in accordance with local regulations. Consignees should complete and return the acknowledgement form. |
| Quantity | 307 |
| Distribution | Nationwide distribution via 6 US distributors |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160513 | Quanta System Surgical Laser fibers Quanta System Spa, Mar 18, 2016 |