Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.

Reason: Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

Code information: Lot #LB1576761, exp. 1/21/2025; and Lot #LB1577308, exp. 1/21/2025; Box UDI-DI 10827002602851, Pouch UDI-DI 00827002602854.

Distribution pattern: US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.