Class 2 Device Recall Biodesign Otologic Butterfly Graft

• Date Initiated by Firm: November 22, 2024
• Date Posted: January 10, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0832-2025
• Recall Event ID: 95961
• 510(K)Number: K232646
• Product Classification: Polymer, ent synthetic-polyamide (mesh or foil material) - Product Code KHJ
• Product: Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
• Code Information: Lot #LB1576761, exp. 1/21/2025; and Lot #LB1577308, exp. 1/21/2025; Box UDI-DI 10827002602851, Pouch UDI-DI 00827002602854.
• Recalling Firm/ Manufacturer: Cook Biotech, Inc.; 1425 Innovation Pl; W Lafayette IN 47906-1000
• For Additional Information Contact: 765-807-7888
• Manufacturer Reason for Recall: Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
• FDA Determined Cause: Under Investigation by firm
• Action: The recalling firm issued two different emails on 11/22/2024, one informing the direct account that the devices either had an incorrect IFU revision (Biodesign Otologic Butterfly Graft, ENT-OTO-BFLY-0.4-0.6) or had an incorrect expiration date (Biodesign Hiatal Hernia Graft, C-PHR, and Biodesign Dural Graft, C-DUR); and the other informing a different direct account that the product had an incorrect IFU revision for two lots (for Biodesign Otologic Butterfly Graft, ENT-OTO-BFLY-0.4-0.6). The direct accounts informed the recalling firm, and the recalling firm issued "URGENT: MEDICAL DEVICE RECALL" letters to its customers dated 12/10/2024. The letters instructed the customers to examine inventory and quarantine affected product, return the products to Cook Biotech Inc with a copy of a completed "Acknowledge and Receipt Form even if you do not have affected product(s) on hand; share notice and immediately report adverse events to Cook Biotech by phone 765-807-7888 or by email to: biotech.feedback@rtix.com. If you have any questions or concerns, please contact Cook Biotech at 765-807-7888.
• Quantity in Commerce: 49 devices
• Distribution: US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KHJ