Recall Z-1695-2021 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
K2M, Inc
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.
| Date | May 7, 2021 |
| Status | Terminated |
| Reason | Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm |
| Root cause | Labeling Change Control |
| Action | Stryker Spine issued an Urgent Medical Device Recall letter to Stryker Spine Branches/Agencies/Distributors/Sales Representatives via e-mail on May 7, 2021 and instructed to identify and return all 3 lots of product to Stryker Spine. Hospital notified by overnight mail (FedX) on 5/10/21. Letter states reason for recall and action to take: 1.Our records indicate product associated with the above catalog and lot numbers were previously distributed to your hospital. Please note this product has already been removed by your local Stryker Sales Representative and/or Stryker Branch or Agency. Thi |
| Quantity | 3 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of MA, MI, NJ, PA, UT and the countries of Italy, Netherlands. |
| FDA record | Open on fda.gov |