Summit Medical, LLC Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Sterile product pouches were not sealed.

Recommended Action

Per FDA guidance

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 and disposed of inventory affected, and that they have none of the product left in inventory. If you have any questions, contact Director of Quality Assurance at 651-789-3939 or email: jesselman@innoviamedical.com.

Distribution

As reported by FDA

CO, FL, GA, LA, ME, MA