Medtronic Catalyft LS Spinal Implant Recall Due to Out-of-Specification Geometry
Medtronic recalls 10 units of Catalyft LS spinal implants due to potential out-of-specification device geometries. The affected implants may not properly support or accommodate patient anatomy during lumbar fusion surgery.
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 recall of a high-risk surgical spinal implant with potential out-of-specification device geometries that could affect surgical outcomes. No illnesses or injuries have been reported. This meets the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling 10 units of the Catalyft LS Expandable Interbody System, Anterior Standalone Cage (Lot NM21K049) due to the potential for out-of-specification device geometries.
The Catalyft LS is an expandable spinal implant designed to be inserted between lumbar or lumbosacral vertebral bodies to provide support and correction during lumbar interbody fusion surgery. The device widths, lengths, heights, and lordotic angles may be out of specification, potentially affecting the implant's ability to properly accommodate patient anatomy. The implant features a central cavity designed to be packed with autogenous bone graft and/or allograft bone.
Affected implants were distributed nationwide to healthcare facilities in Indiana, Wisconsin, Georgia, Oregon, Arkansas, Ohio, Tennessee, Texas, North Carolina, Nebraska, Minnesota, and Florida. Healthcare providers who have received implants from Lot NM21K049 should verify device specifications before surgical use.
The recalled product
- Product
- Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981027722, spinal implant
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Category
- Medical Device — Spinal Implant
- Affected units
- 10
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 (2)
- UDI/DI 00763000465902
- Lot Numbers: NM21K049
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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