# FDA recall Z-1171-2023

> **Summit Medical, LLC** · Class II · device recall initiated 2023-01-13.

## Product

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

## Reason for recall

Sterile product pouches were not sealed.

## 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.

## Key facts

- **Recall number:** Z-1171-2023
- **Recalling firm:** Summit Medical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-01-13
- **Report date:** 2023-03-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Eagan, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1171-2023

## Citation

> AI Analytics. FDA recall Z-1171-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1171-2023. Source: US FDA. Licensed CC0.

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