BEUDAMED
    FDA Recall Open, Classified

    Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)

    Recall: Z-1556-2026 · Initiated February 6, 2026

    Recall

    Recall Number
    Z-1556-2026
    Event Number
    98399
    Firm
    International Life Sciences
    FEI Number
    3010673515
    Product Code
    OWW
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 6, 2026
    Posted
    March 11, 2026
    Address
    8601 Dunwoody Pl, Ste 250, Atlanta, GA, 30350-2513

    Description

    Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)

    Reason

    Augmentation devices failed bacterial endotoxin testing.

    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.