Medtronic spinal implant recall due to out-of-specification device dimensions
Medtronic Catalyft LS Expandable Interbody System spinal implants are being recalled due to out-of-specification device dimensions that may affect proper placement and spinal support.
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: Class II medical device recall for out-of-specification dimensions in a spinal implant. No hospitalization reports or patient injuries documented; the hazard represents potential risk from non-conforming device geometry without reported harm.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling 34 units of the Catalyft LS Expandable Interbody System, a spinal implant used during lumbar and lumbosacral interbody fusion surgeries. The recalled devices may have out-of-specification geometries in their widths, lengths, heights, and lordotic angles that do not properly accommodate patient anatomy as designed.
These devices are designed to be inserted between lumbar or lumbosacral vertebral bodies to provide support and correction during spinal fusion procedures. Each implant contains a central cavity that can be filled with bone graft material to enhance stability. The out-of-specification dimensions could affect the device's ability to provide proper support and stability.
The recalled devices have Lot Numbers NM21J001 and NM21J014 (UDI/DI 00763000465865) and were distributed nationwide.
The recalled product
- Product
- Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, 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 (3)
- UDI/DI 00763000465865
- Lot Numbers: NM21J001
- NM21J014
Distribution
Distributed nationwide across the United States.
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