Recall Z-1171-2023 ยท LFB Button, Nasal Septal
Summit Medical, LLC
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
| Date | Feb 24, 2023 (initiated Jan 13, 2023) |
| Status | Terminated |
| Reason | Sterile product pouches were not sealed. |
| Root cause | Process control |
| Action | The firm issued "URGENT RECALL NOTICE" Letters dated 1/13/2023 via email. The letter explained the issue and requested the consignee remove the product from inventory and inspect the pouch to verify it is sealed. If the pouch is not sealed, the consignee is to cut the product with scissors and dispose of it. Results of their inspection are to be reported to the recalling firm by email using the enclosed form. A number is listed to arrange for replacement product. The consignee is to indicate on the form that they have read and understand the recall instructions, have checked their stock a |
| Quantity | 30 devices |
| Distribution | US Distribution was made to CO, FL, GA, LA, MA, and ME. There was no government/military distribution. OUS Foreign distribution was made to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.