Class 2 Device Recall PedFuse Bone Probe

• Date Initiated by Firm: September 11, 2013
• Date Posted: January 03, 2014
• Recall Status: Terminated on October 08, 2014
• Recall Number: Z-0624-2014
• Recall Event ID: 66273
• 510(K)Number: K123164
• Product Classification: Orthosis, spinal pedicle fixation device - Product Code HXB
• Product: PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
• Code Information: Lot: 012212-001
• FEI Number: 3005977257
• Recalling Firm/ Manufacturer: SpineFrontier, Inc.; 500 Cummings Ctr Ste 3500; Beverly MA 01915-6516
• For Additional Information Contact: 978-232-3990
• Manufacturer Reason for Recall: Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
• FDA Determined Cause: Process change control
• Action: On 9/13/2013, consignees were notified of the recall via email. They were asked to return the recalled product and complete and return the recall acknowledgement form via email or fax.
• Quantity in Commerce: 13 devices
• Distribution: US Distribution: including states of: TX and VA.
• 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 = HXB