Z-1171-2023 Class II Terminated
FDA device recall Z-1171-2023 was initiated by Summit Medical, LLC on Jan 13, 2023 and is designated Class II. Reason for recall: Sterile product pouches were not sealed. The recall status is terminated (terminated Aug 14, 2026). Affected quantity: 30 devices.
Recall details
- Product Type
- Devices
- Report Date
- Mar 8, 2023
- Initiation Date
- Jan 13, 2023
- Termination Date
- Aug 14, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 devices
Product description
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Reason for recall
Sterile product pouches were not sealed.
Distribution pattern
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.
Code information
Lot #219349, Exp. 2027-11-01, UDI (01)00385640065214(17)271101(10)219340
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1171-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026