Class 2 Device Recall ACIFT SoloFuse Fixed Angle Driver

• Date Initiated by Firm: June 13, 2019
• Create Date: July 12, 2019
• Recall Status: Terminated on May 11, 2020
• Recall Number: Z-1973-2019
• Recall Event ID: 83166
• 510(K)Number: K172484
• Product Classification: Intervertebral fusion device with integrated fixation, cervical - Product Code OVE
• Product: A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
• Code Information: Lot EC20
• FEI Number: 3005977257
• Recalling Firm/ Manufacturer: SpineFrontier, Inc.; 350 Main St; Malden MA 02148-5089
• For Additional Information Contact: Kyle Greer; 978-232-3990 Ext. 283
• Manufacturer Reason for Recall: There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.
• FDA Determined Cause: Process control
• Action: Urgent Medical Device Recall letters dated 6/13/19 were emailed to customers.
• Quantity in Commerce: 6
• Distribution: The products were distributed to the following US states: AZ, MD, MO, and FL.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OVE