# FDA recall Z-2122-2023

> **Medtronic Sofamor Danek USA Inc** · Class II · device recall initiated 2023-06-06.

## Product

Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, 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.

## Distribution

US Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX, NC, OR, NE, MN, FL.

## Key facts

- **Recall number:** Z-2122-2023
- **Recalling firm:** Medtronic Sofamor Danek USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-06
- **Report date:** 2023-07-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2122-2023

## Citation

> AI Analytics. FDA recall Z-2122-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2122-2023. Source: US FDA. Licensed CC0.

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