Class 2 Device Recall Eleganz Fusion Screw System

• Date Initiated by Firm: October 02, 2026
• Date Posted: November 10, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0412-2027
• Recall Event ID: 100111
• 510(K)Number: K250251
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: Eleganz Fusion Screw System, 1.8mm Cannulated Drill, Long REF: DI-2004
• Code Information: UDI-DI 00810190980705/Lot Numbers 103611, 106802
• FEI Number: 3029894043
• Recalling Firm/ Manufacturer: Dev4; 1002 Gemini St Ste 129; Houston TX 77058-2746
• For Additional Information Contact: Jeff Seavey; 1-832-2570845
• Manufacturer Reason for Recall: Driver bit included in fusion Screw System may fracture or break during use resulting in intraoperative delay.
• FDA Determined Cause: Device Design
• Action: On November X, 2026, Dev4 issued a revised Urgent: Medical Device Recall notice via email to affected consignees. The initial notification was issued on October 2, 2026. Dev4 ask consignees to take the following actions: 1. Immediately identify and discontinue use of all affected devices in your possession or under your control. 2. Segregate the affected devices to prevent further use or distribution. 3. Return the affected devices to Dev4, labelled with RMA-0001 . Ship ground with UPS G760H7. 4. If you have distributed any affected devices to other facilities, physicians, distributors, or other customers, immediately identify those recipients and provide them with this recall notification. Please provide Dev4 with the identity and contact information of those recipients. Please respond to this email at your earliest opportunity. A response is required even if you do not have any affected product in your possession.
• Quantity in Commerce: 27 units
• Distribution: US Nationwide distribution in the states of MN, IL, FL, TX, RI, CT, SC, NY.
• 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 = LXH