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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 25
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
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.
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