FlexBand recallZ-1556-2026 · International Life Sciences · initiated Feb 6, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from International Life Sciences or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Augmentation devices failed bacterial endotoxin testing.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1556-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 6, 2026
- Posted by the FDA
- Mar 11, 2026
- Recalling firm
- International Life Sciences
- Product code
- OWW
- FDA submissions
- K200503, K230316
- 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.
Product description
Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)
Code information (models, lots, serial numbers)
Lot: RK29976/GTIN: 00850003396248
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- FlexBand TW012Artelon · Fastener, Fixation, Nondegradable, Soft Tissue1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 98399).
- Z-1554-2026 · Open, ClassifiedArtelon FlexBand Dynamic Matrix Ref: 31057
- Z-1555-2026 · Open, ClassifiedArtelon FlexBand Plus Ref: 41054 & 41057
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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