Medtronic Catalyft LS Spinal Implant Recalled for Out-of-Specification Geometry
Medtronic recalls Catalyft LS spinal implants due to potential out-of-specification dimensions. The affected devices may not properly fit or function as intended during spine 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 with no reported illnesses or injuries. The potential for out-of-specification device geometries in a spinal implant constitutes a risk-of-harm product, but no actual patient harm has been reported.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling the Catalyft LS Expandable Interbody System Implant Kit (Anterior Standalone Cage, REF SPS03188) due to the potential for out-of-specification device geometries. Some implants may have widths, lengths, heights, or lordotic angles that do not meet specification requirements.
These spinal implants are designed to be inserted between lumbar or lumbosacral vertebral bodies to provide support and correction during interbody fusion surgery. The implants feature a central cavity designed to accommodate bone graft material to facilitate fusion.
The recall involves 12 units distributed nationwide. Affected lot numbers are: 0001, 0002, 0003, 0004, 0006, 0011, 0014, 0022, 0023, 0027, 0028, and 0029. The devices have been distributed to the following states: Indiana, Wisconsin, Georgia, Oregon, Arkansas, Ohio, Tennessee, Texas, North Carolina, Nebraska, Minnesota, and Florida.
The recalled product
- Product
- Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Category
- Medical Device — Spinal Implant
- Hazard
- out-of-specification-geometry
- 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 (12)
- Lot Numbers: 0001
- 0002
- 0003
- 0004
- 0006
- 0011
- 0014
- 0022
- 0023
- 0027
- 0028
- 0029
Distribution
Distributed nationwide across the United States.
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