Recall Z-2405-2021 ยท GEX Powered Laser Surgical Instrument
Clarus Medical, Llc
Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
| Date | Jul 27, 2021 |
| Status | Terminated |
| Reason | The sterile barrier seal may be compromised. |
| Root cause | Packaging process control |
| Action | The affected Domestic customers, Domestic/International Distributors will be notified with a Field Safety Notice. Domestic/International distributors will also include a request for a list of the Distributor s customers. |
| Quantity | 858 units |
| Distribution | Distribution in US - 18 accounts 1 foreign account |
| FDA record | Open on fda.gov |