Z-1171-2023Class II

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

Name: Z-1171-2023 Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile
Creator: Summit Medical, LLC
Published: 2023-01-13
License: https://open.fda.gov/license/

Summit Medical, LLC / initiated 2023-01-13 / Open, Classified / root cause: manufacturing process

FDA source

Summit Medical, LLC began a recall of Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile on 2023-01-13. FDA classified it as Class II and gives the reason as "Sterile product pouches were not sealed". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1171-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-01-13
Posted: 2023-02-24
Recalling firm: Summit Medical, LLC
Product: Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Product code: LFB Button, Nasal Septal
Reason for recall: Sterile product pouches were not sealed.
Root cause tag: manufacturing process
FDA 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: [email protected].
Quantity in commerce: 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.
Product codes and lots: Lot #219349, Exp. 2027-11-01, UDI (01)00385640065214(17)271101(10)219340

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1171-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1171-2023	Class II	Terminated	Voluntary: Firm initiated	2023-03-08	2023-02-24

Product code LFB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)