Reported Dec 3, 2025 · Ongoing
Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073…
Medtronic Sofamor Danek USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Sofamor Danek USA Inc · 1800 Pyramid Pl · Memphis, TN · 38132-1703
Is this the product you have?
22 of 22 products
| Model / number | Product as published |
|---|---|
6068073. | SPACER 6068073 CATALYFT PL SHORT 7MM. |
6068076. | SPACER 6068076 CATALYFT PL LONG 7MM |
6068093. | SPACER 6068093 CATALYFT PL SHORT 9MM |
6068096. | SPACER 6068096 CATALYFT PL LONG 9MM |
6068113. | SPACER 6068113 CATALYFT PL SHORT 11MM |
6068116. | SPACER 6068116 CATALYFT PL LONG 11MM |
6069073. | SPACER 6069073 CATALYFT PL40 SHORT 7MM |
6069076. | SPACER 6069076 CATALYFT PL40 LONG 7MM |
6069093. | SPACER 6069093 CATALYFT PL40 SHORT 9MM |
6069096. | SPACER 6069096 CATALYFT PL40 LONG 9MM |
6069113. | SPACER 6069113 CATALYFT PL40 SHORT 11MM |
6069116. | SPACER 6069116 CATALYFT PL40 LONG 11MM |
SPS03143. | CATALYFT PL IMPLANT SET |
SPS03144. | CATALYFT PL 40 IMPLANT SET |
SPS04012. | KIT CATALYFT PL IMPLANTS |
SPS04013. | KIT CATALYFT PL 40 IMPLANTS |
SPSJEP40. | CATALYFT PL 40 IMP KIT |
SPSJEP4H. | CATALYFT PL 40 HIGH IMP KIT |
SPSJEP4S. | CATALYFT PL 40 SHORT IMP KIT |
SPSJEP4T. | CATALYFT PL 40 SHORT HIGH IMP KIT |
- Lot codes and dates
- IFUM333023W048E Rev. A Surgical TechniqueM333023W217, Rev. 2.0 1
- Model Number6068073
- GTIN (Lot Numbers)
939 of 939 codes
00763000246693 (0835083W0836192W0837725W0837727W0839577W0839579W0839591W0839593W0839595W0841459W0842257W0842767W0842769W0845001W0845003W0846533W0849546W0849548W0849998W0854451W0856696W0856698W0858703W0868179W0868231W0869637W0869695W0872240W0873202W0874502W0874504W0877435W0878670W0879342W0879887W0881316W0885958W0885960W0886068W0886070W0887342W0888799W0889934W0889936W0891419W0891951W0893270W0893332W0894905W0896952W0896954W0897308W0900773W0900970W0901192W0902362W0903362W0904350W0906154W0907656W
- Model Number6068076
- GTIN (Lot Numbers)
468 of 468 codes
00763000246709 (0831754W0836194W0836196W0837729W0842801W0844113W0848626W0851984W0852133W0852135W0854453W0855324W0858930W0860486W0862453W0869639W0869697W0870551W0873204W0873206W0874508W0877437W0879344W0879346W0879889W0881318W0881320W0881322W0881324W0888801W0891953W0891955W0891957W0891959W0891961W0893334W0895572W0896956W0896958W0897310W0900775W0901194W0902364W0903364W0904722W0906156W0907658W0910204W0910206W0914582W0917664W0920057W0920059W0922963W0924473W0928840W0929162W0931918W0933077W0933079W
- Model Number6068093
- GTIN (Lot Numbers)
399 of 399 codes
00763000246723 (0831756W0837731W0839597W0842803W0844115W0846535W0847976W0849550W0850000W0850415W0850417W0850842W0862455W0865723W0868233W0868235W0869699W0870553W0870555W0870557W0871618W0874997W0874999W0877439W0879348W0879891W0881326W0881328W0881330W0889938W0891963W0893336W0893338W0893340W0895574W0895576W0896960W0898382W0900777W0901196W0902366W0903366W0904724W0906158W0907660W0910208W0910210W0914584W0914586W0917666W0920061W0920063W0922035W0922037W0922965W0924475W0929164W0929166W0931920W0933083W
- Model Number6068096
- GTIN (Lot Numbers)
350 of 350 codes
00763000246730 (0831758W0836198W0836200W0836202W0837733W0842805W0844111W0848628W0849622W0852137W0852139W0854455W0855326W0860488W0860490W0862457W0864032W0864038W0871620W0872100W0873208W0881015W0881332W0885962W0885964W0887344W0887346W0887348W0888803W0889940W0891965W0893342W0893344W0898384W0900779W0901198W0901200W0902368W0903368W0904726W0906160W0907662W0910212W0910214W0914588W0914590W0917668W0920065W0920067W0924477W0929168W0929170W0931962W0935296W0935298W0935300W0936468W0937876W0937878W0939332W
- Model Number6068113
- GTIN (Lot Numbers)
132 of 132 codes
00763000246754 (0831760W0836204W0837735W0839599W0841051W0842331W0844117W0846537W0847978W0849572W0849574W0868237W0870559W0874510W0879893W0885966W0887350W0888805W0896962W0898386W0900781W0901202W0902370W0903370W0905342W0910216W0922967W0924479W0927268W0929172W0939334W0951524W0952501W0952766W0954078W0957565W0957567W0961530W0962776W0968368W0969283W0973091W0976750W0977734W0995692W0997492W0997494W0997496W0999005W1000102W1002992W1006264W1031690W1032322W1032591W1033180W1033182W1033184W1033186W1033188W
- Model Number6068116
- GTIN (Lot Numbers)
169 of 169 codes
00763000246761 (0831762W0837093W0837737W0845005W0845007W0850844W0853143W0854459W0858932W0861112W0862459W0864040W0874512W0875981W0881017W0881334W0881336W0888807W0891967W0893346W0896964W0896966W0898388W0905344W0906452W0910218W0914592W0914594W0920069W0926363W0927270W0929174W0931964W0937880W0939336W0942916W0943495W0945705W0951526W0952503W0952768W0952770W0955366W0957569W0957571W0959054W0964248W0964250W0965516W0973093W0976752W0976754W0976756W0977736W0978661W0983632W0987048W0989575W0994928W0995694W
- Model Number6069073
- GTIN (Lot Numbers)
291 of 291 codes
00763000246785 (0831764W0837739W0837741W0839601W0839603W0842333W0849576W0853145W0854461W0855328W0857973W0858934W0862491W0865725W0874361W0875983W0877441W0879350W0879352W0885968W0887352W0888809W0889942W0891969W0896968W0898390W0900783W0901204W0901206W0902372W0903372W0905346W0907664W0917670W0917672W0918868W0918870W0918872W0918874W0920071W0920073W0922039W0922969W0924481W0939338W0942918W0943497W0943499W0945707W0951528W0952505W0952507W0952772W0952774W0955368W0957573W0960500W0962778W0962780W0964632W
- Model Number6069076
- GTIN (Lot Number)
299 of 299 codes
00763000246792 (0831766W0836206W0837743W0839605W0839607W0842335W0842807W0854463W0856700W0857975W0861114W0862493W0865727W0869721W0870561W0870563W0870565W0875985W0881019W0885970W0885972W0887354W0887356W0895578W0896970W0898392W0900785W0903374W0905348W0906456W0907666W0910220W0910222W0914596W0914598W0917674W0918876W0918878W0920075W0926365W0926367W0927302W0931966W0935302W0935304W0937882W0937884W0939340W0942920W0947412W0947414W0948530W0950156W0951530W0954080W0957575W0959056W0959058W0959060W0960502W
- Model Number6069093
- GTIN (Lot Numbers)
134 of 134 codes
00763000246815 (0835085W0836208W0839609W0841053W0842337W0844119W0847980W0848630W0854465W0857977W0858936W0861116W0864042W0864598W0865729W0868239W0868241W0868243W0870567W0874516W0877443W0885974W0887358W0887360W0896972W0898394W0901208W0905350W0906458W0910224W0910226W0918880W0918882W0920077W0922081W0923071W0924483W0951532W0952509W0954082W0957579W0957581W0961532W0962782W0964634W0969291W0977742W0977744W0978667W0982551W0995144W0995700W0997504W0998723W1000252W1005212W1011418W1012066W1012068W1012776W
- Amount recalled
- 275,260 units
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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