Recall Z-1697-2021
K2M, Inc · initiated May 7, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot Number: NCNE-4437924 Expiration Date 12-10-2025
Reason for recall
Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
FDA-determined cause: Labeling Change Control
Action taken
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. This communication is being made for notification purposes only; there are no additional product(s) to return for this matter. Stryker has contained all product associated with this recall. 2.Please assist us in meeting our regulatory obligation by completing and signing the enclosed Business Reply Form and email a copy to Stryker Spine at SpineRegulatoryActions@Stryker.com, or fax the form to 201.575.4675. 3.Maintain awareness of this communication internally within your facility. If you have any questions or concerns, please contact Stryker Regulatory Compliance at 201.749.8090. OUS: Europe is the only region outside of the US that received parts from these lots. All parts in Europe have been quarantined at Stryker Europe locations (Netherlands and Italy) prior to distribution to customers. Accordingly, there are no notifications required for Europe
Details
- Recall number
- Z-1697-2021
- Initiated
- May 7, 2021
- Terminated
- March 8, 2023
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Quantity
- 3 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of MA, MI, NJ, PA, UT and the countries of Italy, Netherlands.
- Recalling firm
- K2M, Inc, Leesburg, VA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1695-2021 Class II | Cascadia AN Interbody Convex 10x22x14mm Catalog Number: 6101-2102214NC-G2 Lumbar…Mislabeled product labeling references incorrect length or height, or length and height for specific Lots… | 05/07/2021Terminated |
| Z-1696-2021 Class II | Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar…Mislabeled product labeling references incorrect length or height, or length and height for specific Lots… | 05/07/2021Terminated |