medical Class II Updated 2023-07-19

Medtronic Sofamor Danek USA Inc recalls Medtronic Catalyft LS Expandable Interbody System Implant Ki

Recalled Product

Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 0001, 0002, 0003, 0004, 0006, 0011, 0014, 0022, 0023, 0027, 0028, 0029
View official government recall

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