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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker

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  Class 2 Device Recall Stryker see related information
Date Initiated by Firm May 07, 2021
Create Date June 01, 2021
Recall Status1 Terminated 3 on March 08, 2023
Recall Number Z-1695-2021
Recall Event ID 87905
510(K)Number K172009  K150481  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
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.
Code Information Lot Number: NCMR-4437922  Expiration Date 12-10-2025
Recalling Firm/
Manufacturer		 K2M, Inc
600 Hope Pkwy SE
Leesburg VA 20175-4428
For Additional Information Contact Margarita Karan
201-749-8389
Manufacturer 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 2		 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 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
Quantity in Commerce 3 units
Distribution Worldwide distribution - US Nationwide distribution in the states of MA, MI, NJ, PA, UT and the countries of Italy, Netherlands.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MAX and Original Applicant = K2M, Inc.
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