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.
This recall has been terminated (originally issued November 21, 2012).
- Company
- Spinefrontier, Inc.
- Recall Initiated
- August 28, 2012
- Posted
- November 21, 2012
- Terminated
- June 11, 2015
- Recall Number
- Z-0412-2013
- Quantity
- 17 units
- Firm Location
- Beverly, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Inspan Compressors may break at weld causing a loss of compression
Distribution
Worldwide Distribution-USA (nationwide) including PR and the states of FL, MA, MO, OK, and TX, and the country of Mexico.
Lot / Code Info
Lot Numbers: SFP02323, SFP02323R, and SFP02323RR
Root Cause
Device Design
Action Taken
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.
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