Cascadia AN Interbody Convex 10x22x14mm Catalog Number:… — Class II medical device recall Z-1695-2021
Terminated recall by K2M, Inc, reported 2021-06-09, distributed nationwide. Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Siz
| Recall number | Z-1695-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | K2M, Inc, Leesburg, VA, United States |
| Recall initiated | 2021-05-07 |
| Classified | 2021-06-01 |
| Reported by FDA | 2021-06-09 |
| Terminated | 2023-03-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | IT, NL |
| Quantity | 3 units |
| Reason classes | labeling |
| Lot numbers | NCMR-4437922 |
| Model numbers | 6101-2102214NC-G2 |
| Expiration dates | 2025-12-10 |
Product
Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-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.
Reason for recall
Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1695-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.