Recall archive / FDA device enforcement
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile. — FDA record Z-1171-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 13, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
- Reason
- Sterile product pouches were not sealed.
- Classification
- Class II
- Recalling firm
- Summit Medical, LLC
- Quantity
- 30 devices
- Agency-reported status
- Terminated
- Source record identifier
- Z-1171-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot #219349, Exp. 2027-11-01, UDI (01)00385640065214(17)271101(10)219340 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Mar 8, 2023
- Recall initiation date
- Jan 13, 2023
- Center classification date
- Feb 24, 2023
- Termination date
- Aug 14, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.