Recall Z-2119-2023 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Medtronic Sofamor Danek USA Inc
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant
| Date | Jul 10, 2023 (initiated Jun 6, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 06/06/2023 by UPS 2-day delivery. The notice explained the problem , risk, and requested the following actions be taken: "" For purchased inventory not consumed during a procedure: o Identify and quarantine any unused impacted product(s). Refer to the table above for impacted products. o Return the impacted product(s) to Medtronic following the instructions in the enclosed Customer Confirmation Form. " For Medtronic owned product at your facility: o Your Medtronic Sales Representative will locate and return this |
| Quantity | 25 units |
| Distribution | US Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX, NC, OR, NE, MN, FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212653 | Catalyft LS Expandable Interbody System Medtronic Sofamor Danek USA, Inc., Nov 19, 2021 |