International Life Sciences recalls Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm…

Augmentation devices failed bacterial endotoxin testing.

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.

• FDA enforcement recordOfficial FDA database entry for Z-1556-2026
• FDA 510(k) clearance · K200503The device's official FDA premarket clearance record
• FDA 510(k) clearance · K230316The device's official FDA premarket clearance record
• FDA device classification · OWWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.3300The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find International Life SciencesSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.