# FDA recall Z-0580-2026

> **Medtronic Sofamor Danek USA Inc** · Class II · device recall initiated 2025-09-16.

## Product

Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers:    1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073.    2. SPACER 6068076 CATALYFT PL LONG 7MM, Model Number: 6068076.     3. SPACER 6068093 CATALYFT PL SHORT 9MM, Model Number: 6068093.     4. SPACER 6068096 CATALYFT PL LONG 9MM, Model Number: 6068096.     5. SPACER 6068113 CATALYFT PL SHORT 11MM, Model Number: 6068113.     6. SPACER 6068116 CATALYFT PL LONG 11MM, Model Number: 6068116.     7. SPACER 6069073 CATALYFT PL40 SHORT 7MM, Model Number: 6069073.     8. SPACER 6069076 CATALYFT PL40 LONG 7MM, Model Number: 6069076.     9. SPACER 6069093 CATALYFT PL40 SHORT 9MM, Model Number: 6069093.     10. SPACER 6069096 CATALYFT PL40 LONG 9MM, Model Number: 6069096.     11. SPACER 6069113 CATALYFT PL40 SHORT 11MM, Model Number: 6069113.     12. SPACER 6069116 CATALYFT PL40 LONG 11MM, Model Number: 6069116.     13. CATALYFT PL IMPLANT SET, Model Number: SPS03143.     14. CATALYFT

## Reason for recall

Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.

## Distribution

Worldwide distribution - US Nationwide and Puerto Rico. The countries of Australia, Austria, Belgium, Canada, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Netherlands, New Caledonia, New Zealand, Norway, Portugal, Reunion, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-0580-2026
- **Recalling firm:** Medtronic Sofamor Danek USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-16
- **Report date:** 2025-12-03

- **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-0580-2026

## Citation

> AI Analytics. FDA recall Z-0580-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0580-2026. Source: US FDA. Licensed CC0.

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