Medtronic Catalyft LS Expandable Interbody System — Class II medical device recall Z-2119-2023
Ongoing recall by Medtronic Sofamor Danek USA Inc, reported 2023-07-19, distributed nationwide. There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angl
| Recall number | Z-2119-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Sofamor Danek USA Inc, Memphis, TN, United States |
| Recall initiated | 2023-06-06 |
| Classified | 2023-07-10 |
| Reported by FDA | 2023-07-19 |
| Distributed | Nationwide (US) |
| Quantity | 25 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00763000465889 |
| Lot numbers | NM21J039, NM21M026 |
| Model numbers | 981025522 |
Product
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2119-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.