CLASS II ONGOING Device recall · Reported 19 Jul 2023 · FDA Enforcement Report
Medtronic Catalyft LS Expandable Interbody System Implant recalled
Medtronic Sofamor Danek USA is recalling Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, distributed nationwide in the US. The recall was initiated on 6 Jun 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2123-2023
- FDA event ID
- 92567
- Recalling firm
- Medtronic Sofamor Danek USA, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Jun 2023
- FDA classified
- 10 Jul 2023
- Reported
- 19 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Spinal Implants
Timeline
| 6 Jun 2023 | Recall initiated by company | |
| 10 Jul 2023 | Classified by FDA | +34 days |
| 19 Jul 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
Where it was distributed
US Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX, NC, OR, NE, MN, FL.
Nationwide ArkansasFloridaGeorgiaMinnesotaNorth CarolinaNebraskaOhioOregonTennesseeTexasWisconsin
Questions about this recall
Is Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage recalled?
Yes. Medtronic Sofamor Danek USA recalled Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage on 6 Jun 2023. The recall is Class II and its status is Ongoing. Recall number Z-2123-2023.
Why was it recalled?
There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
Which lots are affected?
Lot Numbers: 0001, 0002, 0003, 0004, 0006, 0011, 0014, 0022, 0023, 0027, 0028, 0029
Where was it sold?
US Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX, NC, OR, NE, MN, FL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medtronic Sofamor Danek USA
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