Reported Jun 9, 2021 · Terminated
Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body…
K2M, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: K2M, Inc · 600 Hope Pkwy SE · Leesburg, VA · 20175-4428
Is this the product you have?
- Cascadia AN Interbody
- Convex 10x22x15mm Catalog Number6101-2102215NC-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 to fusion in patients with degenerative disc disease
- Lot codes and dates
- Lot NumberNCMT-4437923 Expiration Date 12-10-2025
- Amount recalled
- 7 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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