The Recall Desk
HighFDA (Devices)·Z-2121-2023·Announced 2023-07-19

Medtronic Catalyft LS Spinal Implant Recall Due to Out-of-Specification Geometry

Medtronic recalls 10 units of Catalyft LS spinal implants due to potential out-of-specification device geometries. The affected implants may not properly support or accommodate patient anatomy during lumbar fusion surgery.

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: FDA Class II recall of a high-risk surgical spinal implant with potential out-of-specification device geometries that could affect surgical outcomes. No illnesses or injuries have been reported. This meets the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic Sofamor Danek USA Inc is recalling 10 units of the Catalyft LS Expandable Interbody System, Anterior Standalone Cage (Lot NM21K049) due to the potential for out-of-specification device geometries.

The Catalyft LS is an expandable spinal implant designed to be inserted between lumbar or lumbosacral vertebral bodies to provide support and correction during lumbar interbody fusion surgery. The device widths, lengths, heights, and lordotic angles may be out of specification, potentially affecting the implant's ability to properly accommodate patient anatomy. The implant features a central cavity designed to be packed with autogenous bone graft and/or allograft bone.

Affected implants were distributed nationwide to healthcare facilities in Indiana, Wisconsin, Georgia, Oregon, Arkansas, Ohio, Tennessee, Texas, North Carolina, Nebraska, Minnesota, and Florida. Healthcare providers who have received implants from Lot NM21K049 should verify device specifications before surgical use.

The recalled product

Product
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
Manufacturer
Medtronic Sofamor Danek USA Inc
Category
Medical Device — Spinal Implant
Hazard
  • out-of-specification
  • device-defect

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 (2)

  • UDI/DI 00763000465902
  • Lot Numbers: NM21K049

Distribution

Distributed nationwide across the United States.

Related recalls

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