Recall Z-0580-2026 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Medtronic Sofamor Danek USA Inc
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 11
| Date | Nov 21, 2025 (initiated Sep 16, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Labeling design |
| Action | 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. |
| Quantity | 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, Israel, Italy, Japan, Netherlands, New Caledonia, New Zealand, Norway, Portugal, Reunion, Saudi Arabia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210425 | Catalyft PL Expandable Interbody System Medtronic Sofamor Danek USA, Inc., May 24, 2021 |