Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are intervertebral body fusion devices in...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1697-2021.
Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1697-2021.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact K2m, Inc or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1697-2021.
K2M, Inc
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
K2m, Inc Recall FAQ
K2m, Inc is the subject of a medical implants safety report: Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-G2 Lumbar implants are intervertebral body fusion devices in.... The notice was published on May 7, 2021 by the U.S. Food and Drug Administration (FDA). Approximately 3 units are potentially affected.