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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Detail

Product Description 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.
Recall Number Z-0412-2013
Classification Class II
Code Info Lot Numbers: SFP02323, SFP02323R, and SFP02323RR
Product Distributed Qty 17 units
Reason For Recall Inspan Compressors may break at weld causing a loss of compression

Event Detail

Event Id 63144
Product Type Devices
Status Completed
Recalling Firm SpineFrontier, Inc.
City Beverly
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) including PR and the states of FL, MA, MO, OK, and TX, and the country of Mexico.