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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Medtronic Sofamor Danek USA Inc: 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 bo

Agency Publication Date: July 10, 2023
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Affected Products

Product: Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant

UDI/DI 00763000465865, Lot Numbers: NM21J001, NM21J014

Lot Numbers:
Numbers
Product: Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant

UDI/DI 00763000465872, Lot Numbers: NM21J004, NM22A032

Lot Numbers:
Numbers
Product: Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant

UDI/DI 00763000465889, Lot Numbers: NM21J039, NM21M026

Lot Numbers:
Numbers
Product: Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant

UDI/DI 00763000465896, Lot Numbers: NM21K046, NM21L032, NM22A042

Lot Numbers:
Numbers
Product: Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant

UDI/DI 00763000465902, Lot Numbers: NM21K049

Lot Numbers:
Numbers
Product: Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant

UDI/DI 00763000465919, Lot Numbers: NM21K050, NM22B007

Lot Numbers:
Numbers
Product: 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

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92567
Status: Active
Manufacturer: Medtronic Sofamor Danek USA Inc
Manufactured In: United States
Units Affected: 7 products (34 units; 8 units; 25 units; 11 units; 10 units; 8 units; 12 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.