Z-1171-2023 Class II Terminated
FDA device recall Z-1171-2023 was initiated by Summit Medical, LLC on January 13, 2023 and is designated Class II. Reason for recall: Sterile product pouches were not sealed. The recall status is terminated (terminated August 14, 2026). Affected quantity: 30 devices.
Recall Details
- Product Type
- Devices
- Report Date
- March 8, 2023
- Initiation Date
- January 13, 2023
- Termination Date
- August 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