FDA Device recall Z-0580-2026
Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM…
- FDA Device
- Class II
- ongoing
- Published 2025-12-03
On 2025-12-03 the FDA classified a Class II recall of Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM… by Medtronic Sofamor Danek Usa, citing expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical techn….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0580-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-16 |
| Published | 2025-12-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Sofamor Danek Usa |
| Distribution | US |
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 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.
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.
Identifiers
| code_info | IFU: M333023W048E Rev. A Surgical TechniqueM333023W217, Rev. 2.0 1. Model Number: 6068073. GTIN (Lot Numbers): 0076…IFU: M333023W048E Rev. A Surgical TechniqueM333023W217, Rev. 2.0 1. Model Number: 6068073. GTIN (Lot Numbers): 00763000246693 (0835083W, 0836192W, 0837725W, 0837727W, 0839577W, 0839579W, 0839591W, 0839593W, 0839595W, 0841459W, 0842257W, 0842767W, 0842769W, 0845001W, 0845003W, 0846533W, 0849546W, 0849548W, 0849998W, 0854451W, 0856696W, 0856698W, 0858703W, 0868179W, 0868231W, 0869637W, 0869695W, 0872240W, 0873202W, 0874502W, 0874504W, 0877435W, 0878670W, 0879342W, 0879887W, 0881316W, 0885958W, 0885960W, 0886068W, 0886070W, 0887342W, 0888799W, 0889934W, 0889936W, 0891419W, 0891951W, 0893270W, 0893332W, 0894905W, 0896952W, 0896954W, 0897308W, 0900773W, 0900970W, 0901192W, 0902362W, 0903362W, 0904350W, 0906154W, 0907656W, 0908818W, 0908820W, 0910150W, 0910202W, 0914572W, 0914574W, 0914576W, 0914578W, 0914580W, 0917478W, 0917480W, 0917662W, 0918071W, 0918073W, 0918075W, 0918077W, 0918858W, 0918860W, 0918862W, 0918864W, 0918866W, 0918886W, 0918888W, 0922033W, 0924471W, 0925397W, 0926139W, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0580-2026%22
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