Recall archive / FDA device enforcement

Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073... — FDA record Z-0580-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 16, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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.
Classification: Class II
Recalling firm: Medtronic Sofamor Danek USA Inc
Quantity: 275,260 units
Agency-reported status: Ongoing
Source record identifier: Z-0580-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	IFU: M333023W048E Rev. A Surgical TechniqueM333023W217, Rev. 2.0 1. Model Number: 6068073. 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1050572W, 1050574W, 1050576W, 1050578W, 1050580W, 1050584W, 1050586W, 1050590W, 1050592W, 1052420W, 1056849W, 1057484W, 1057486W, 1059122W, 1059124W, 1059126W, 1059128W, 1059673W, 1059679W, 1059681W, 1060018W, 1060042W, 1061132W, 1061136W, 1061138W, 1061140W, H5962482, H5969220, H5979175, H5979177, H5980995, H5981839, H5983795, H5991698, H5993288, H6018660, H6024652, H6030042, H6032572, H6040357, 1002451W, 1008576W, 1040457W, 1056901W, H6028216). 2. Model Number: 6068076. GTIN (Lot Numbers): 00763000246709 (0831754W, 0836194W, 0836196W, 0837729W, 0842801W, 0844113W, 0848626W, 0851984W, 0852133W, 0852135W, 0854453W, 0855324W, 0858930W, 0860486W, 0862453W, 0869639W, 0869697W, 0870551W, 0873204W, 0873206W, 0874508W, 0877437W, 0879344W, 0879346W, 0879889W, 0881318W, 0881320W, 0881322W, 0881324W, 0888801W, 0891953W, 0891955W, 0891957W, 0891959W, 0891961W, 0893334W, 0895572W, 0896956W, 0896958W, 0897310W, 0900775W, 0901194W, 0902364W, 0903364W, 0904722W, 0906156W, 0907658W, 0910204W, 0910206W, 0914582W, 0917664W, 0920057W, 0920059W, 0922963W, 0924473W, 0928840W, 0929162W, 0931918W, 0933077W, 0933079W, 0933081W, 0935292W, 0935294W, 0936460W, 0937874W, 0939328W, 0940207W, 0940209W, 0941916W, 0943259W, 0943491W, 0943959W, 0947406W, 0948522W, 0948524W, 0951518W, 0952754W, 0952756W, 0954066W, 0954068W, 0955354W, 0955356W, 0955504W, 0955506W, 0957553W, 0957555W, 0959042W, 0959044W, 0961522W, 0962116W, 0962118W, 0962120W, 0962772W, 0962774W, 0967197W, 0967199W, 0967201W, 0969067W, 0973085W, 0974331W, 0974333W, 0975730W, 0976604W, 0976606W, 0976608W, 0976610W, 0976742W, 0978655W, 0978657W, 0980758W, 0980760W, 0980762W, 0983624W, 0986390W, 0989391W, 0992001W, 0992003W, 0992005W, 0992007W, 0992009W, 0993274W, 0993628W, 0993630W, 0995670W, 1002345W, 1002455W, 1002457W, 1003070W, 1003602W, 1004292W, 1004294W, 1004648W, 1004650W, 1005202W, 1007162W, 1007164W, 1007166W, 1007168W, 1007170W, 1007172W, 1007174W, 1007573W, 1007575W, 1007577W, 1007579W, 1007581W, 1007583W, 1010252W, 1010254W, 1010256W, 1010258W, 1010260W, 1010262W, 1010264W, 1010729W, 1011392W, 1011394W, 1011396W, 1011904W, 1011906W, 1013087W, 1013089W, 1013091W, 1013093W, 1013095W, 1013097W, 1013099W, 1014066W, 1014068W, 1014070W, 1014072W, 1014074W, 1014856W, 1014858W, 1014860W, 1015566W, 1015568W, 1015570W, 1015572W, 1015574W, 1015576W, 1015578W, 1016360W, 1018664W, 1018666W, 1019189W, 1019441W, 1019443W, 1019445W, 1019447W, 1019449W, 1020208W, 1020210W, 1020212W, 1020214W, 1020216W, 1020218W, 1021427W, 1021429W, 1021471W, 1021473W, 1021475W, 1021769W, 1022752W, 1024223W, 1025162W, 1026251W, 1026829W, 1027614W, 1027616W, 1027618W, 1027620W, 1028551W, 1030261W, 1031319W, 1031331W, 1031333W, 1031496W, 1031498W, 1031500W, 1031682W, 1032064W, 1032066W, 1032068W, 1032581W, 1032583W, 1032585W, 1033164W, 1033166W, 1033168W, 1033170W, 1033172W, 1033934W, 1034572W, 1034574W, 1034576W, 1034578W, 1034582W, 1034584W, 1036020W, ...

Label field

Details supplied by the agency

Lot, code or applicability

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, 0926361W, 0927266W, 0931914W, 0931916W, 0933069W, 0933071W, 0933073W, 0933075W, 0934823W, 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1057484W, 1057486W, 1057994W, 1057996W, 1057998W, 1058000W, 1058102W, 1058104W, 1058106W, 1058108W, 1059122W, 1059124W, 1059126W, 1059128W, 1059673W, 1059675W, 1059677W, 1059679W, 1059681W, 1059685W, 1060016W, 1060018W, 1060042W, 1061130W, 1061132W, 1061134W, 1061136W, 1061138W, 1061140W, 1062398W, 1062400W, 1062402W, 1062404W, 1062406W, 1062410W, 1062412W, 1062414W, 1062418W, 1063591W, 1063593W, 1063595W, 1063597W, 1063599W, 1063601W, 1063603W, 1063605W, 1064184W, 1064186W, 1064188W, 1064190W, 1064192W, 1064194W, 1064196W, 1064198W, 1064688W, 1064690W, 1064935W, 1064937W, 1064939W, 1065454W, 1065456W, 1065458W, 1065460W, 1065472W, 1065474W, 1065476W, 1065882W, 1065884W, 1066272W, 1066274W, 1066469W, 1067027W, 1067029W, 1067031W, 1067033W, 1067035W, 1067037W, 1067039W, 1067721W, 1067723W, 1067725W, 1068010W, 1068312W, 1068314W, 1068316W, 1068318W, 1068320W, 1068322W, 1068324W, 1069172W, 1069174W, 1069176W, 1069178W, 1069679W, 1069683W, 1069685W, 1069687W, 1069689W, 1069691W, 1069693W, 1069697W, 1069699W, 1070304W, 1070308W, 1070310W, 1070405W, 1070407W, 1070409W, 1071241W, 1071243W, 1071245W, 1071247W, 1071249W, 1071251W, 1071253W, 1071255W, 1071257W, 1071259W, 1071476W, 1071478W, 1072574W, 1072580W, 1072582W, H5949771, H5958086, H5960046, H5960960, H5962266, H5962482, H5963060, H5966757, H5966776, H5967705, H5968960, H5969220, H5969817, H5975991, H5979175, H5979177, H5980995, H5981839, H5983795, H5984549, H5990897, H5991698, H5993288, H5995524, H5996143, H5996159, H5996493, H5996497, H5998670, H6000399, H6004407, H6009899, H6010724, H6010732, H6013796, H6014111, H6014312, H6014313, H6014549, H6014720, H6015908, H6018002, H6018003, H6018630, H6018659, H6018660, H6018663, H6018664, H6018668, H6020623, H6023750, H6023890, H6024117, H6024652, H6030042, H6032572, H6032577, H6040357, H6041546, H6048295, H6048303, H6060354, H6060358, H6060602, H6060606, H6062043); 00763000529567 (0856698W, 0858703W, 0868179W, 0868231W, 0869637W, 0869695W, 0872240W, 0885958W, 0886068W, 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0999209W, 1000720W, 1002203W, 1002209W, 1003055W, 1003059W, 1003061W, 1003068W, 1003590W, 1004007W, 1005095W, 1006066W, 1006608W, 1007435W, 1007561W, 1007567W, 1007569W, 1008574W, 1008578W, 1008907W, 1008909W, 1009421W, 1009425W, 1009431W, 1010466W, 1010542W, 1010550W, 1010552W, 1012752W, 1013085W, 1016350W, 1016356W, 1017284W, 1017288W, 1017294W, 1018228W, 1018232W, 1018236W, 1018324W, 1018326W, 1018658W, 1019499W, 1020114W, 1020116W, 1020120W, 1020513W, 1021729W, 1021767W, 1023316W, 1024213W, 1024215W, 1024217W, 1025154W, 1025160W, 1026564W, 1026570W, 1026825W, 1027612W, 1028545W, 1028547W, 1028704W, 1034570W, 1035141W, 1035145W, 1035149W, 1035151W, 1035155W, 1035157W, 1035159W, 1035161W, 1036542W, 1037691W, 1037693W, 1038210W, 1038250W, 1039194W, 1039592W, 1040466W, 1040468W, 1042955W, 1042959W, 1042963W, 1043672W, 1043676W, 1044340W, 1044589W, 1044641W, 1044717W, 1045694W, 1046302W, 1046304W, 1046306W, 1047619W, 1048281W, 1048283W, 1048285W, 1048289W, 1048291W, 1048293W, 1048882W, 1050572W, 1050574W, 1050576W, 1050578W, 1050580W, 1050584W, 1050586W, 1050590W, 1050592W, 1052420W, 1056849W, 1057484W, 1057486W, 1059122W, 1059124W, 1059126W, 1059128W, 1059673W, 1059679W, 1059681W, 1060018W, 1060042W, 1061132W, 1061136W, 1061138W, 1061140W, H5962482, H5969220, H5979175, H5979177, H5980995, H5981839, H5983795, H5991698, H5993288, H6018660, H6024652, H6030042, H6032572, H6040357, 1002451W, 1008576W, 1040457W, 1056901W, H6028216). 2. Model Number: 6068076. GTIN (Lot Numbers): 00763000246709 (0831754W, 0836194W, 0836196W, 0837729W, 0842801W, 0844113W, 0848626W, 0851984W, 0852133W, 0852135W, 0854453W, 0855324W, 0858930W, 0860486W, 0862453W, 0869639W, 0869697W, 0870551W, 0873204W, 0873206W, 0874508W, 0877437W, 0879344W, 0879346W, 0879889W, 0881318W, 0881320W, 0881322W, 0881324W, 0888801W, 0891953W, 0891955W, 0891957W, 0891959W, 0891961W, 0893334W, 0895572W, 0896956W, 0896958W, 0897310W, 0900775W, 0901194W, 0902364W, 0903364W, 0904722W, 0906156W, 0907658W, 0910204W, 0910206W, 0914582W, 0917664W, 0920057W, 0920059W, 0922963W, 0924473W, 0928840W, 0929162W, 0931918W, 0933077W, 0933079W, 0933081W, 0935292W, 0935294W, 0936460W, 0937874W, 0939328W, 0940207W, 0940209W, 0941916W, 0943259W, 0943491W, 0943959W, 0947406W, 0948522W, 0948524W, 0951518W, 0952754W, 0952756W, 0954066W, 0954068W, 0955354W, 0955356W, 0955504W, 0955506W, 0957553W, 0957555W, 0959042W, 0959044W, 0961522W, 0962116W, 0962118W, 0962120W, 0962772W, 0962774W, 0967197W, 0967199W, 0967201W, 0969067W, 0973085W, 0974331W, 0974333W, 0975730W, 0976604W, 0976606W, 0976608W, 0976610W, 0976742W, 0978655W, 0978657W, 0980758W, 0980760W, 0980762W, 0983624W, 0986390W, 0989391W, 0992001W, 0992003W, 0992005W, 0992007W, 0992009W, 0993274W, 0993628W, 0993630W, 0995670W, 1002345W, 1002455W, 1002457W, 1003070W, 1003602W, 1004292W, 1004294W, 1004648W, 1004650W, 1005202W, 1007162W, 1007164W, 1007166W, 1007168W, 1007170W, 1007172W, 1007174W, 1007573W, 1007575W, 1007577W, 1007579W, 1007581W, 1007583W, 1010252W, 1010254W, 1010256W, 1010258W, 1010260W, 1010262W, 1010264W, 1010729W, 1011392W, 1011394W, 1011396W, 1011904W, 1011906W, 1013087W, 1013089W, 1013091W, 1013093W, 1013095W, 1013097W, 1013099W, 1014066W, 1014068W, 1014070W, 1014072W, 1014074W, 1014856W, 1014858W, 1014860W, 1015566W, 1015568W, 1015570W, 1015572W, 1015574W, 1015576W, 1015578W, 1016360W, 1018664W, 1018666W, 1019189W, 1019441W, 1019443W, 1019445W, 1019447W, 1019449W, 1020208W, 1020210W, 1020212W, 1020214W, 1020216W, 1020218W, 1021427W, 1021429W, 1021471W, 1021473W, 1021475W, 1021769W, 1022752W, 1024223W, 1025162W, 1026251W, 1026829W, 1027614W, 1027616W, 1027618W, 1027620W, 1028551W, 1030261W, 1031319W, 1031331W, 1031333W, 1031496W, 1031498W, 1031500W, 1031682W, 1032064W, 1032066W, 1032068W, 1032581W, 1032583W, 1032585W, 1033164W, 1033166W, 1033168W, 1033170W, 1033172W, 1033934W, 1034572W, 1034574W, 1034576W, 1034578W, 1034582W, 1034584W, 1036020W, ...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Dec 3, 2025
Recall initiation date: Sep 16, 2025
Center classification date: Nov 21, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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