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U.S. Department of Health and Human Services

Class 2 Device Recall PedFuse Bone Probe

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  Class 2 Device Recall PedFuse Bone Probe see related information
Date Initiated by Firm September 11, 2013
Date Posted January 03, 2014
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = SPINEFRONTIER, INC.
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