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U.S. Department of Health and Human Services

Class 2 Device Recall Spine Frontier Inspan Compressor

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  Class 2 Device Recall Spine Frontier Inspan Compressor see related information
Date Initiated by Firm August 28, 2012
Date Posting Updated 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
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