FDAFDA · Food and drugs·Recall number Z-0412-2013
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.
Published November 28, 2012 · Recall initiated: August 28, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Inspan Compressors may break at weld causing a loss of compression
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- SpineFrontier, Inc.
- Distributor
- Worldwide Distribution-USA (nationwide) including PR and the states of FL, MA, MO, OK, and TX, and the country of Mexico.
- Lot
- Lot Numbers: SFP02323, SFP02323R, and SFP02323RR
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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