Medtronic Sofamor Danek USA Inc Recall 92567
Description: Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
Medtronic Sofamor Danek USA Inc Recall 92567 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2123-2023 |
| Event ID | 92567 |
| Event Description | Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX, NC, OR, NE, MN, FL. |
| Quantity | 12 units |
| Recall Reason | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. |
| Device Classification | 20230719 |
| Device Code Info | Lot Numbers: 0001, 0002, 0003, 0004, 0006, 0011, 0014, 0022, 0023, 0027, 0028, 0029 |
| Center Classification Date | 20230710 |
| Recall Initiation Date | 20230606 |
| Recalling Firm | Medtronic Sofamor Danek USA Inc |
| Initial Notification | Letter |
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