Date Initiated by Firm |
August 28, 2012 |
Date Posted |
November 21, 2012 |
Recall Status1 |
Terminated 3 on June 11, 2015 |
Recall Number |
Z-0412-2013 |
Recall Event ID |
63144 |
510(K)Number |
K093438
|
Product Classification |
Appliance, fixation, spinal interlaminal - Product Code KWP
|
Product |
Spine Frontier Inspan compressors Part Number: 11-60004.
Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant. |
Code Information |
Lot Numbers: SFP02323, SFP02323R, and SFP02323RR |
Recalling Firm/ Manufacturer |
SpineFrontier, Inc. 500 Cummings Ctr Ste 3500 Beverly MA 01915-6516
|
For Additional Information Contact |
Mathew King 978-279-9271
|
Manufacturer Reason for Recall |
Inspan Compressors may break at weld causing a loss of compression
|
FDA Determined Cause 2 |
Device Design |
Action |
Spine Frontier issued e-mail notices to customers on May 14, 2012 advising of the potential for breakage. Units were replaced with weld free design. |
Quantity in Commerce |
17 units |
Distribution |
Worldwide Distribution-USA (nationwide) including PR and the states of FL, MA, MO, OK, and TX, and the country of Mexico. |
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 = KWP and Original Applicant = PARADIGM SPINE, LLC
|