FDA Medical Device Recalls (openFDA)
Summit Medical, LLC: Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
- Recall number
- Z-1171-2023
- Recalling firm
- Summit Medical, LLC
- Product
- Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
- Status
- Open, Classified
- Initiated
- 2023-01-13
- Posted
- 2023-02-24
- Terminated
- not on file
- 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 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.
- 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.
- Lot, serial or model codes
- Lot #219349, Exp. 2027-11-01, UDI (01)00385640065214(17)271101(10)219340
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LFB
- Firm FEI
- 3008719017
- Firm city
- Eagan
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28