FDA recall Z-1171-2023

Summit Medical, LLC · Class II · device

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

Status
Ongoing
Initiation date
2023-01-13
Report date
2023-03-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Eagan, MN, United States

Primary source

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