Z-0412-2013 Class II Terminated
FDA device recall Z-0412-2013 was initiated by SpineFrontier, Inc. on Aug 28, 2012 and is designated Class II. Reason for recall: Inspan Compressors may break at weld causing a loss of compression The recall status is terminated (terminated Jun 11, 2015). Affected quantity: 17 units.
Recall details
- Product Type
- Devices
- Report Date
- Nov 28, 2012
- Initiation Date
- Aug 28, 2012
- Termination Date
- Jun 11, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 units
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.
Reason for recall
Inspan Compressors may break at weld causing a loss of compression
Distribution pattern
Worldwide Distribution-USA (nationwide) including PR and the states of FL, MA, MO, OK, and TX, and the country of Mexico.
Code information
Lot Numbers: SFP02323, SFP02323R, and SFP02323RR
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0412-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026