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 PL 40 IMPLANT SET, Model Number: SPS03144. 15. KIT CATALYFT PL IMPLANTS, Model Number: SPS04012. 16. KIT CATALYFT PL 40 IMPLANTS, Model Number: SPS04013. 17. CATALYFT PL 40 IMP KIT, Model Number: SPSJEP40. 18. CATALYFT PL 40 HIGH IMP KIT, Model Number: SPSJEP4H. 19. CATALYFT PL 40 SHORT IMP KIT, Model Number: SPSJEP4S. 20. CATALYFT PL 40 SHORT HIGH IMP KIT, Model Number: SPSJEP4T. 21. CATALYFT PL STRAIGHT HIGH IMP KIT, Model Number: SPSJEPSH. 22. CATALYFT PL STRAIGHT IMP KIT, Model Number: SPSJEPSI. These systems utilize the following affected Instructions for Use (IFU), Document M333023W048E, and Surgical Technique Guide, Document M333023W217.
FDA Recall Z-0580-2026 · Posted 2025-11-21
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Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusOpen, Classified
Product CodeMAX
Date Initiated2025-09-16
Product Quantity275,260 units
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.
Firm 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.
Root Cause
Labeling design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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