Z-1696-2021Class II

Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral...

Name: Z-1696-2021 Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral...
Creator: K2M, Inc
Published: 2021-05-07
License: https://open.fda.gov/license/

K2M, Inc / initiated 2021-05-07 / Terminated / root cause: labeling and UDI

FDA source

K2M, Inc began a recall of Cascadia AN Interbody Convex 10x22x15mm Catalog Number: 6101-2102215NC-G2 Lumbar implants are intervertebral body fusion devices indicated for use with... on 2021-05-07. FDA classified it as Class II and gives the reason as "Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1696-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-07
Posted: 2021-06-01
Terminated: 2023-03-08
Recalling firm: K2M, Inc
Product: 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 with degenerative disc disease.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
Root cause tag: labeling and UDI
FDA 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. 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 [email protected], 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
Quantity in commerce: 7 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of MA, MI, NJ, PA, UT and the countries of Italy, Netherlands.
Product codes and lots: Lot Number: NCMT-4437923 Expiration Date 12-10-2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1696-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1695-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1696-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01
Z-1697-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-09	2021-06-01

Product code MAX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)