Recall Z-0832-2025 ยท KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Cook Biotech, Inc.
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
| Date | Jan 10, 2025 (initiated Nov 22, 2024) |
| Status | Open, Classified |
| Reason | Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. |
| Root 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 REC |
| Quantity | 49 devices |
| Distribution | US (domestic) Distribution to states of IN and MI; and OUS (foreign) to Canada and South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) Cook Biotech Incorporated, May 24, 2024 |