The Recall Desk
HighFDA (Devices)·Z-2118-2023·Announced 2023-07-19

Medtronic Catalyft LS spinal implant recalled for out-of-specification device dimensions

Medtronic is recalling eight units of Catalyft LS Expandable Interbody System spinal implants due to potential out-of-specification device dimensions that could affect surgical fitting and spinal 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: FDA Class II medical device with potential out-of-specification geometries that could affect surgical fit of a critical spinal implant. No illnesses or injuries reported. Specification defects on a high-risk implant device present risk-of-harm, qualifying as High per the rubric.

Plain-English summary

Medtronic Sofamor Danek USA Inc is recalling eight units of the Catalyft LS Expandable Interbody System, a spinal implant used in lumbar and lumbosacral interbody fusion surgeries. The recalled devices have UDI/DI 00763000465872 and Lot Numbers NM21J004 and NM22A032.

The devices were recalled due to potential out-of-specification geometries affecting widths, lengths, heights, and lordotic angles. The Catalyft LS is designed to be inserted between vertebral bodies to provide support and correction during fusion procedures. Out-of-specification dimensions could affect proper surgical fit and device function.

The eight recalled units were distributed nationwide to healthcare facilities in Indiana, Wisconsin, Georgia, Oregon, Arkansas, Ohio, Tennessee, Texas, North Carolina, Nebraska, Minnesota, and Florida.

Healthcare providers and patients with information about these recalled devices are advised to contact Medtronic or report adverse events to the FDA.

The recalled product

Product
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981023325, spinal implant
Manufacturer
Medtronic Sofamor Danek USA Inc
Category
Medical Device — Spinal Implant
Hazard
Affected units
8

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 (3)

  • UDI/DI 00763000465872
  • Lot Numbers: NM21J004
  • NM22A032

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 7 recalled by Medtronic Sofamor Danek USA Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Related recalls

Same manufacturer · Medtronic Sofamor Danek USA Inc

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