Medtronic Catalyft LS Spinal Implant Recall for Out-of-Spec Geometry
Medtronic is recalling Catalyft LS spinal implants due to potential out-of-specification device geometries that may not properly accommodate patient anatomy.
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: FDA Class II medical device with a structural defect (out-of-specification geometries) that could affect surgical outcomes and device function. No illnesses or injuries are reported in the source material.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling the Catalyft LS Expandable Interbody System, Anterior Standalone Cage (Lot Numbers NM21K050, NM22B007) due to potential out-of-specification device geometries, including variations in widths, lengths, heights, and lordotic angles.
These implants are spinal devices designed to be inserted between lumbar or lumbosacral vertebral bodies to provide support and correction during lumbar interbody fusion surgeries. Out-of-specification geometries could affect the device's ability to properly accommodate patient anatomy and provide the intended structural support.
Approximately 8 units have been distributed nationwide to healthcare facilities in Indiana, Wisconsin, Georgia, Oregon, Arkansas, Ohio, Tennessee, Texas, North Carolina, Nebraska, Minnesota, and Florida. Patients who have received this implant should contact their surgeon if they have concerns about their spinal fusion procedure or device placement.
Healthcare providers should immediately verify they do not have affected product and contact Medtronic for recall instructions. The device is identified by UDI/DI 00763000465919.
The recalled product
- Product
- Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027725, spinal implant
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Category
- Medical Device — Spinal Implant
- 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 00763000465919
- Lot Numbers: NM21K050
- NM22B007
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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