Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CA
FDA device recall Z-0580-2026 · posted 2025-11-21 · Open, Classified
Recall details
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- 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.
- Action taken
- Medtronic Sofamor Danek notified consignees on about 09/16/2025 via letter. Consignees were informed of updates to the IFU and surgical guide. Consignees were instructed to share the notification within each facility with clinical users of the affected systems and to complete and return the provided Customer Acknowledgement form.
- Root cause
- Labeling design
- Status
- Open, Classified
- Product code
- MAX
- Quantity affected
- 275,260 units
- 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, Isra
- Date initiated
- 2025-09-16
- Date posted
- 2025-11-21
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Catalyft PL Expandable Interbody System (K210425) | Medtronic Sofamor Danek USA, Inc. | 2021-05-24 |