Device product

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

Z-1171-2023

January 13, 2023

Class II

Product summary

Firm: Summit Medical, LLC
Event: Event 91527
Status: Ongoing
Classification: Class II
Quantity: 30 devices
Official record key: device-enforcement:Z-1171-2023

Official wording

Reason: Sterile product pouches were not sealed.

Code information: Lot #219349, Exp. 2027-11-01, UDI (01)00385640065214(17)271101(10)219340

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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Sterile product pouches were not sealed.