Official recall record
Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-06-06
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Medtronic Sofamor Danek USA Inc
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-08-12 · US FDA — Medical Devices
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to - 2026-08-12 · US FDA — Medical Devices
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to - 2023-09-26 · US FDA — Medical Devices
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
All 9 official recall notices naming Medtronic Sofamor Danek USA Inc on this site →