K2M Cascadia AN Interbody Lumbar Implants recalled for mislabeled dimensions
K2M, Inc is recalling Cascadia AN Interbody Convex lumbar implants (Lot NCMT-4437923) due to product labeling that references incorrect length or height dimensions. Seven units were distributed to the US and internationally.
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 a labeling error on a surgical implant device where incorrect dimensional information constitutes a risk-of-harm product. No illnesses or injuries are reported, and the hazard is theoretical; per the rubric, such cases cannot exceed score 3.
Plain-English summary
K2M, Inc is recalling Cascadia AN Interbody Convex lumbar implants (Catalog Number 6101-2102215NC-G2, Lot Number NCMT-4437923) because the product labeling references incorrect length or height dimensions for certain device sizes. The affected size configurations include 10x22x14mm, 10x28x14mm, and 10x22x15mm.
These devices are intervertebral body fusion implants intended for use with bone graft material in spinal fusion surgery for patients with degenerative disc disease. Incorrect dimension information on the product labeling could result in improper device selection or placement during surgery, potentially compromising surgical outcomes.
Seven units have been distributed worldwide, including to the United States (Massachusetts, Michigan, New Jersey, Pennsylvania, and Utah) and to Italy and the Netherlands. The product expiration date is December 10, 2025.
Patients who have received this implant should consult their healthcare provider regarding any concerns. Healthcare providers should verify that the actual physical device dimensions match the intended specifications and contact K2M, Inc for clarification regarding affected devices.
The recalled product
- Product
- Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as anadjunct t
- Manufacturer
- K2M, Inc
- Category
- Medical Device — Spinal Implants
- Hazard
- mislabeling
- dimension-error
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 (1)
- Lot Number: NCMT-4437923 Expiration Date 12-10-2025
Distribution
Distributed nationwide across the United States.
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