Stradis Medical, LLC dba Stradis Healthcare: STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray

Hazard

Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.

Details from the source

Reason for recall: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Distribution: US nationwide distribution, and Canada. Quantity: 20 units Lot/code info: UDI/DI (case) M75240561BIP1, UDI/DI (kit)M75240561BIP0, Serial/Lot Numbers: 22228490663, 22242491516, 22242491516

UPC codes

22228490663, 22242491516

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.