Class II U.S. Food and Drug Administration

Medtronic Sofamor Danek USA Inc Catalyft PL & PL40 recall: Expandable interbody system cage may loose height or collapse (loss

Recall published 11 months ago

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.

The hazard: Fall or tip-over hazard

A fall or tip-over risk prompted this notice. With furniture, the typical victim is a toddler who used a drawer as a step.

What the notice says: 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.

Why it matters: The product can tip, collapse or give way under normal use. Furniture tip-overs in particular kill and injure young children, usually when a child climbs on an open drawer.

Symptoms and when to call a doctor

After a fall or a tip-over involving a child, watch for a headache that gets worse, repeated vomiting, drowsiness that is hard to rouse, confusion, unequal pupils, clear fluid from the nose or ear, or a seizure, and call 911 if any of these appear. Any fall onto the head in a baby under one, or any loss of consciousness at any age, needs to be assessed the same day.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0580-2026
Published
December 3, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medtronic Sofamor Danek USA Inc
Product type
Medical devices
Units affected
275,260 units
Distribution
Nationwide
Made in
United States
Lot / code info
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, 0934825W, 0934827W, 0934998W, 0935000W, 0936452W, 0936454W, 0936456W, 0936458W, 0937870W, 0937872W, 0939113W, 0939115W, 0939324W, 0939326W, 0941080W, 0941364W, 0941366W, 0941912W, 0941914W, 0942912W, 0943255W, 0943257W, 0943953W, 0943955W, 0943957W, 0945701W, 0945946W, 0945948W, 0945950W, 0950146W, 0950148W, 0950150W, 0951512W, 0951514W, 0951516W, 0952750W, 0952752W, 0954062W, 0954064W, 0954430W, 0955352W, 0955892W, 0955894W, 0957547W, 0957549W, 0957551W, 0958456W, 0958458W, 0958460W, 0958854W, 0958856W, 0958858W, 0958860W, 0959360W, 0959425W, 0959427W, 0959429W, 0959431W, 0959433W, 0960482W, 0960484W, 0960486W, 0960488W, 0960490W, 0960492W, 0960494W, 0960496W, 0960498W, 0965510W, 0965512W, 0965514W, 0967296W, 0967298W, 0967300W, 0969065W, 0973081W, 0973083W, 0973837W, 0973839W, 0976737W, 0976739W, 0977571W, 0977573W, 0978651W, 0978653W, 0980738W, 0980740W, 0980752W, 0980754W, 0980756W, 0982541W, 0982543W, 0983620W, 0983622W, 0985251W, 0985253W, 0985576W, 0985580W, 0985582W, 0985584W, 0985586W, 0986386W, 0986388W, 0990940W, 0990959W, 0990962W, 0990964W, 0993272W, 0998279W, 0999003W, 0999209W, 0999869W, 0999908W, 1000718W, 1000720W, 1002203W, 1002205W, 1002207W, 1002209W, 1002341W, 1002343W, 1002445W, 1002447W, 1002449W, 1002453W, 1003053W, 1003055W, 1003057W, 1003059W, 1003061W, 1003064W, 1003066W, 1003068W, 1003590W, 1004007W, 1005087W, 1005089W, 1005091W, 1005093W, 1005095W, 1005097W, 1005099W, 1005113W, 1005115W, 1005117W, 1005119W, 1005681W, 1005683W, 1006066W, 1006068W, 1006608W, 1006610W, 1007433W, 1007435W, 1007439W, 1007561W, 1007563W, 1007565W, 1007567W, 1007569W, 1007571W, 1008244W, 1008246W, 1008248W, 1008250W, 1008572W, 1008574W, 1008578W, 1008580W, 1008905W, 1008907W, 1008909W, 1009421W, 1009423W, 1009425W, 1009427W, 1009429W, 1009431W, 1009433W, 1009435W, 1010466W, 1010468W, 1010470W, 1010542W, 1010544W, 1010546W, 1010548W, 1010550W, 1010552W, 1010554W, 1012752W, 1012754W, 1013081W, 1013085W, 1014062W, 1014064W, 1014852W, 1014854W, 1015300W, 1015562W, 1015564W, 1016350W, 1016352W, 1016354W, 1016356W, 1016358W, 1017284W, 1017286W, 1017288W, 1017290W, 1017292W, 1017294W, 1017296W, 1018228W, 1018232W, 1018234W, 1018236W, 1018324W, 1018326W, 1018652W, 1018654W, 1018656W, 1018658W, 1018660W, 1018662W, 1019499W, 1020114W, 1020116W, 1020118W, 1020120W, 1020202W, 1020204W, 1020206W, 1020513W, 1020515W, 1020517W, 1021425W, 1021729W, 1021761W, 1021763W, 1021765W, 1021767W, 1023316W, 1024125W, 1024127W, 1024129W, 1024213W, 1024215W, 1024217W, 1024221W, 1025110W, 1025154W, 1025156W, 1025158W, 1025160W, 1026564W, 1026566W, 1026568W, 1026570W, 1026823W, 1026825W, 1026827W, 1027612W, 1028469W, 1028541W, 1028545W, 1028547W, 1028549W, 1028704W, 1028706W, 1030249W, 1033162W, 1033932W, 1034564W, 1034566W, 1034568W, 1034570W, 1035135W, 1035137W, 1035139W, 1035141W, 1035145W, 1035149W, 1035151W, 1035153W, 1035155W, 1035157W, 1035159W, 1035161W, 1036540W, 1036542W, 10…
UPC codes
00763000246693

Products covered by this recall

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.

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00763000246693

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Fall

Medtronic Sofamor Danek USA Inc — A fall or tip-over risk prompted this notice. With furniture, the typical victim is a toddler who used a drawer as a step.

  1. Stop using the product and, if it is furniture, move it out of a child’s room until the remedy is done.
  2. Anchor tall furniture to the wall with a tip-over restraint — this is worth doing for every chest and bookcase in the house, not just this one.
  3. Keep TVs, toys and anything else tempting off the top of tall furniture, because that is what draws a child to climb.
  4. Inspect similar units from the same range, since a weak joint or fastener usually affects a whole production run.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • Paid by card? A chargeback for goods that are unfit for sale is a legitimate fallback once the company has had a fair chance.
  • Send the photos they asked for in the format they asked for. A missing date code is the single commonest reason a claim sits unprocessed.
  • Give it ten working days, then chase in writing and quote your claim reference.

Company contact: Medtronic Sofamor Danek USA Inc — 1800 Pyramid Pl, Memphis, TN, 38132-1703

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medtronic Sofamor Danek USA Inc medical devices 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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00763000246693. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the product and, if it is furniture, move it out of a child’s room until the remedy is done.

Can I get my money back?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

Where was the recalled product sold?

It was distributed nationwide.

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