Medtronic Catalyft LS Spinal Implants Recalled for Out-of-Specification Geometry
Medtronic is recalling 11 units of its Catalyft LS Expandable Interbody System spinal implants due to potential out-of-specification dimensions that could affect surgical fit and stability.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a spinal implant with out-of-specification geometry that could affect surgical outcome and spinal fusion stability. No injuries, hospitalizations, or complications have been reported in the source. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling 11 units of the Catalyft LS Expandable Interbody System, Anterior Standalone Cage (REF 981025525), a spinal implant used during lumbar interbody fusion surgery. The recalled devices have been identified as having potential out-of-specification geometry, including variations in width, length, height, and lordotic angle.
These devices are designed to be inserted between lumbar or lumbosacral vertebral bodies to provide support and correction during fusion surgery. The out-of-specification geometry could affect the devices' ability to properly fit and function in the patient's anatomy, potentially compromising the stability and effectiveness of the spinal fusion.
The recall affects 11 units distributed nationwide across the following states: Indiana, Wisconsin, Georgia, Oregon, Arkansas, Ohio, Tennessee, Texas, North Carolina, Nebraska, Minnesota, and Florida. The affected lot numbers are NM21K046, NM21L032, and NM22A042.
Patients and healthcare providers who may have received these implants should contact Medtronic Sofamor Danek USA Inc for guidance. Patients with concerns about their implants should consult their surgical team immediately.
The recalled product
- Product
- Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025525, spinal implant
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Hazard
- out-of-specification-geometry
- implant-defect
- spinal-fusion-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI/DI 00763000465896
- Lot Numbers: NM21K046
- NM21L032
- NM22A042
Distribution
Distributed nationwide across the United States.
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