Z-2524-2023 Class II Ongoing
FDA device recall Z-2524-2023 was initiated by Medtronic Sofamor Danek USA Inc on July 31, 2023 and is designated Class II. Reason for recall: The incorrect product labeling was applied to the product indicating the wrong size of product. The recall status is ongoing. Affected quantity: 55 pouches.
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2023
- Initiation Date
- July 31, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55 pouches
Product Description
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
Reason for Recall
The incorrect product labeling was applied to the product indicating the wrong size of product.
Distribution Pattern
US Nationwide distribution in the states of ID, IN, MN, NC, NY, OH, OR, WA, and WI.
Code Information
Serial numbers: A57958-011, A57958-012, A57958-013, A57958-014, A57958-015, A57958-016, A57958-017, A57958-018, A57958-019, A57958-020, A57958-021, A57958-022, A57958-023, A57958-024, A57958-025, A57958-026, A57958-027, A57958-028, A57958-029, A57958-030, A57958-031, A57958-033, A57958-034, A57958-035, A57958-036, A57958-037, A57958-038, A57958-048, A57958-050, A57958-051, A57958-052, A57958-053, A57958-054, A57958-055, A57958-056, A57958-057, A57958-058, A57958-059, A57958-060, A57958-066, A57958-069, A57958-070, A57958-072, A57958-073, A57958-074, A57958-075, A57958-076, A57958-077, A57958-078, A57958-079, A57958-080, A57958-081, A57958-082, A57958-085, A57958- 086. Exp. 2/15/2025. UDI-DI 00613994986467