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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 Recall
Spine Frontier Inspan Compressor
see related information
Date Posted November 21, 2012
Recall Status1 Open
Recall Number Z-0412-2013
Recall Event ID 63144
Premarket Notification
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, Massachusetts 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KWP and Original Applicant = PARADIGM SPINE, LLC
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