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.
|