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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Spine Frontier Inspan Compressor		see related information
Date Posted November 21, 2012
Recall Number Z-0412-2013
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
Reason for
Recall		 Inspan Compressors may break at weld causing a loss of compression
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.
 
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