CLASS II Device recall · Reported 8 Mar 2023 · FDA Enforcement Report
Nasal Septal Button, Medium recalled by Summit Medical
Summit Medical is recalling Summit Medical Nasal Septal Button, Medium, distributed in Colorado, Florida, Georgia, Louisiana, Massachusetts, Maine. The recall was initiated on 13 Jan 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1171-2023
- FDA event ID
- 91527
- Recalling firm
- Summit Medical, Eagan, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jan 2023
- FDA classified
- 24 Feb 2023
- Reported
- 8 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 13 Jan 2023 | Recall initiated by company | |
| 24 Feb 2023 | Classified by FDA | +42 days |
| 8 Mar 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sterile product pouches were not sealed.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Where it was distributed
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.
Questions about this recall
Is Nasal Septal Button, Medium recalled?
Yes. Summit Medical recalled Nasal Septal Button, Medium on 13 Jan 2023. The recall is Class II and its status is Terminated. Recall number Z-1171-2023.
Why was it recalled?
Sterile product pouches were not sealed.
Which lots are affected?
Lot #219349, Exp. 2027-11-01, UDI (01)00385640065214(17)271101(10)219340
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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