ETHICON, LLC recalls STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device

Potential for barb non-engagement.

On August 15, 2025, Ethicon, LLC issued an " Urgent Medical Device Recall (Removal)" Notification. Ethicon asked consignees to take the following actions: 1. Examine stock and quarantine affected product. 2. Share notification with all personnel. 3. Complete the response form and and fax 888-202-5865 or email ethicon7924@sedgwick.com 4. Return all unused product. 5. Keep this notice visibly posed for awareness. 6. If assistance is needed, please contact Sedgwick at 888-266-7913 and reference Event # 7924.

• FDA enforcement recordOfficial FDA database entry for Z-2605-2025
• FDA 510(k) clearance · K192144The device's official FDA premarket clearance record
• FDA device classification · NEWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4840The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find ETHICON, LLCSearch 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.