Class 2 Device Recall FlexBand Dynamic Matrix

• Date Initiated by Firm: February 06, 2026
• Date Posted: March 11, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1554-2026
• Recall Event ID: 98399
• 510(K)Number: K200503 K230316
• Product Classification: Mesh, surgical, absorbable, orthopaedics, reinforcement of tendon - Product Code OWW
• Product: Artelon FlexBand Dynamic Matrix Ref: 31057
• Code Information: A10011001/GTIN: 00850003396019
• FEI Number: 3010673515
• Recalling Firm/ Manufacturer: International Life Sciences; 8601 Dunwoody Pl Ste 250; Atlanta GA 30350-2513
• For Additional Information Contact: Dannielle Stap; 901-598-8510
• Manufacturer Reason for Recall: Augmentation devices failed bacterial endotoxin testing.
• FDA Determined Cause: Process control
• Action: On February 6, 2026, International Life Science ( subsidiary of Stryker) issued a Urgent: Medical Device Recall notification to affected consignees. International Life Science asked consignees to take the following actions: 1. Immediately check your internal inventory to locate the product, remove them from their point of use, and isolate/quarantine the unit(s) to prevent accidental use. 2. Review the product issue and risks as communicated and communicate the issue as appropriate in your organization. 3. Return the enclosed business reply form by email a. Response is required, even if you may not have any physical inventory on site anymore. 4. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the return of your product(s). 5. Maintain awareness of this communication internally until required actions have been completed within your facility. 6. If you have further distributed the affected product, please notify the applicable parties. a. If possible, inform us if any of the subject devices have been distributed to other organizations, including contact details, so that we can inform the recipients appropriately. b. If you are a distributor, note that you are responsible for notifying your affected customers.
• Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OWW