K2M, Inc Recall 87905
Description: Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-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.
K2M, Inc Recall 87905 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1697-2021 |
| Event ID | 87905 |
| Event Description | Cascadia AN Interbody Convex 10x28x14mm Catalog Number: 6101-2102814NC-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. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of MA, MI, NJ, PA, UT and the countries of Italy, Netherlands. |
| Quantity | 3 units |
| Recall Reason | Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm |
| Device Classification | 20210609 |
| Device Code Info | Lot Number: NCNE-4437924 Expiration Date 12-10-2025 |
| Center Classification Date | 20210601 |
| Recall Initiation Date | 20210507 |
| Recalling Firm | K2M, Inc |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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