Medtronic Catalyft LS Spinal Implants Recalled for Out-of-Specification Dimensions
Medtronic recalls 25 units of Catalyft LS spinal implants (lot numbers NM21J039, NM21M026) due to out-of-specification device dimensions that may affect surgical fit and function.
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 with no reported illnesses or injuries. The defect involves out-of-specification device dimensions in a spinal implant. Per the rubric, recalls for risk-of-harm products where injury has not yet been reported qualify as High severity.
Plain-English summary
Medtronic Sofamor Danek USA Inc. is recalling 25 units of the Catalyft LS Expandable Interbody System, Anterior Standalone Cage (REF 981025522), a spinal implant used in lumbar interbody fusion surgeries. The device is designed to be inserted between lumbar or lumbosacral vertebral bodies to provide support and correction, with a central cavity for bone graft material.
The recall was initiated due to the potential for out-of-specification device geometries. The affected implants may have widths, lengths, heights, and lordotic angles that do not meet manufacturing specifications, potentially affecting the device's fit and function during surgery.
The recall affects 25 units distributed nationwide. Affected lot numbers are NM21J039 and NM21M026 (UDI/DI 00763000465889). Distribution included the states of Indiana, Wisconsin, Georgia, Oregon, Arkansas, Ohio, Tennessee, Texas, North Carolina, Nebraska, Minnesota, and Florida.
The recalled product
- Product
- Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Category
- Medical Device — Spinal Implant
- Hazard
- manufacturing-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 00763000465889
- Lot Numbers: NM21J039
- NM21M026
Distribution
Distributed nationwide across the United States.
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