Lower risk Medical device recall · FDA · Published June 6, 2023

Medtronic Catalyft LS Spinal Implant Kit Recall: Potential Fit Issues

Medtronic recalls specific spinal implant kits (REF SPS03188) due to possible incorrect device geometries that could affect spinal fusion surgery. Affected kits include lot numbers 0001-0029.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2123-2023Medical device Medtronic ›

Lower-risk 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.

Take action

Contact the company

Recalling firmMedtronic Sofamor Danek USA Inc1800 Pyramid Pl · Memphis, TN 38132-1703

✎ GovInfoNow plain-language explainer

Medtronic is recalling certain spinal implant kits for possible incorrect device geometries that might not fit properly during surgery. This could lead to improper spinal fusion if the implants don't match the patient's anatomy. Read more at govinfonow.com/recall/57882-medtronic-catalyft-ls-spinal-implant-kit-recall-potential-fit-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/57882-medtronic-catalyft-ls-spinal-implant-kit-recall-potential-fit-issues · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2123-2023

Cite this page

“Medtronic Catalyft LS Spinal Implant Kit Recall: Potential Fit Issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57882-medtronic-catalyft-ls-spinal-implant-kit-recall-potential-fit-issues. Based on FDA recall #Z-2123-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2123-2023%22&limit=1).

The FDA announced on June 6, 2023, that Medtronic Sofamor Danek USA Inc is recalling the Medtronic Catalyft LS Expandable Interbody System Implant Kit and Anterior Standalone Cage due to potential out-of-specification device geometries. The agency issued recall number Z-2123-2023 for the Class II voluntary recall.

How to tell if you have it

Brand: Medtronic
Product: Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage
REF: SPS03188
Lot Numbers: 0001, 0002, 0003, 0004, 0006, 0011, 0014, 0022, 0023, 0027, 0028, 0029
Quantity: 12 units

The hazard

According to the FDA, there is the potential for out-of-specification device geometries, including widths, lengths, heights, and lordotic angles. These devices are designed to be inserted between two lumbar or lumbosacral vertebral bodies to provide support and correction during lumbar interbody fusion surgeries.

Context

GovInfoNow's records show that Medtronic Sofamor Danek USA Inc has had 19 other recalls on record since December 6, 2017. Other recent recalls of similar products include Medtronic 6069073 (September 16, 2025), Medtronic Sofamor Danek Grafton DBM Crunch (September 26, 2023), and Medtronic Sofamor Danek Magnifuse Bone Graft (July 31, 2023). Other recent recalls of similar products include IsoTis OsteoBallast Spine Implants (July 2, 2026), Straumann GM Helix Dental Implant (July 13, 2026), and Alphatec LIF NAV Osteotome 10mm (January 2, 2026).

How to tell if you have this one

Check if your spinal implant kit has the reference number SPS03188 and lot numbers 0001 through 0029. This kit is used for lumbar spine fusion surgeries.

Brand
Medtronic
Category
Medical device

FDA recall event · 7 products

All 7 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX, NC, OR, NE, MN, FL.

Recall number	Product, codes & lots	Quantity
Z-2117-2023	Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant; UDI/DI 00763000465865, Lot Numbers: NM21J001, NM21J014	34 units
Z-2118-2023	Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant; UDI/DI 00763000465872, Lot Numbers: NM21J004, NM22A032	8 units
Z-2119-2023	Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant; UDI/DI 00763000465889, Lot Numbers: NM21J039, NM21M026	25 units
Z-2120-2023	Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant; UDI/DI 00763000465896, Lot Numbers: NM21K046, NM21L032, NM22A042	11 units
Z-2121-2023	Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant; UDI/DI 00763000465902, Lot Numbers: NM21K049	10 units
Z-2122-2023	Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant; UDI/DI 00763000465919, Lot Numbers: NM21K050, NM22B007	8 units
Z-2123-2023	Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit; Lot Numbers: 0001, 0002, 0003, 0004, 0006, 0011, 0014, 0022, 0023, 0027, 0028, 0029	12 units

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Identify if your implant kit has the reference number SPS03188 and lot numbers 0001-0029.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 12 states.

FDA distribution: “US Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX, NC, OR, NE, MN, FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arkansas, Florida, Georgia, Indiana, Minnesota, Nebraska, North Carolina, Ohio, Oregon, Tennessee, Texas, Wisconsin.

Recall timeline

FDA published this recall 43 days after the firm started it.

Jun 6, 2023Firm started the recall
Jul 10, 2023FDA classified it Class II
Jul 19, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this a safety hazard for patients?

The recall addresses potential fit issues during surgery, but the hazard is not described as causing immediate injury in normal use.

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Link to this recall

<a href="https://govinfonow.com/recall/57882-medtronic-catalyft-ls-spinal-implant-kit-recall-potential-fit-issues">Medtronic Catalyft LS Spinal Implant Kit Recall: Potential Fit Issues (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2123-2023 (June 6, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2123-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.