Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1696-2021 — 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 to fusion in patients

U.S. FDA — Device Enforcement · United States · 2021-05-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1696-2021
Date of alert: 2021-05-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: K2M, Inc
Product category: device
Product type: Devices

Reported risk: Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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