Summit Medical Nasal Septal Button, Medium, 5cm, REF… recallZ-1171-2023 · Summit Medical, LLC · initiated Jan 13, 2023
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Summit Medical, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Sterile product pouches were not sealed.
FDA root cause category: Process control
What the company is doing
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: [email protected].
Recall details
- Recall number
- Z-1171-2023
- Status
- Terminated
- Initiated by the company
- Jan 13, 2023
- Posted by the FDA
- Feb 24, 2023
- Recalling firm
- Summit Medical, LLC
- Quantity
- 30 devices
- Product code
- LFB
- 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.
Product description
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Code information (models, lots, serial numbers)
Lot #219349, Exp. 2027-11-01, UDI (01)00385640065214(17)271101(10)219340
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SUMMIT MEDICAL SP-78105Summit Medical, Inc. · Button, Nasal Septal1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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