Class 2 Device Recall SeaSpine Polyaxial Head

• Date Initiated by Firm: May 28, 2026
• Date Posted: July 20, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2762-2026
• Recall Event ID: 99221
• 510(K)Number: K173882
• Product Classification: Thoracolumbosacral pedicle screw system - Product Code NKB
• Product: SeaSpine Polyaxial Head REF Number: 41-3010
• Code Information: UDI: 10889981155117; Affected Lots: AW199682G, AW199684G.
• FEI Number: 3012120772
• Recalling Firm/ Manufacturer: SEASPINE ORTHOPEDICS CORPORATION; 5770 Armada Dr; Carlsbad CA 92008-4608
• For Additional Information Contact: Audrey Mudderman; 760-224-0177
• Manufacturer Reason for Recall: Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
• FDA Determined Cause: Process change control
• Action: On June 16, 2026, Orthofix issued a updated Urgent Medical Device Recall notification to provide additional information concerning the recall. Initial notification was issued on May 28, 206. Orthofix ask consignees to take the following actions: 1. Discontinue use of affected lots, 2.Immediately identify and quarantine any affected product. 3. If product is identified, Orthofix will facilitate the return. 4. Complete and return the attached Acknowledgement and Receipt Form. 5. This recall notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred.
• Quantity in Commerce: 796 units
• Distribution: Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kansas, Maryland, Michigan, Missouri, Mississippi, Montana, Nevada, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, and Wyoming. The countries of Chile and Australia.
• 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 = NKB