Spine Frontier Inspan compressors recallZ-0412-2013 · SpineFrontier, Inc. · initiated Aug 28, 2012
Class II Terminated All recalls posted in November 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from SpineFrontier, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Inspan Compressors may break at weld causing a loss of compression
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0412-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 28, 2012
- Posted by the FDA
- Nov 21, 2012
- Recalling firm
- SpineFrontier, Inc.
- Quantity
- 17 units
- Product code
- KWP
- FDA submissions
- K093438
- Distribution
- Worldwide Distribution-USA (nationwide) including PR and the states of FL, MA, MO, OK, and TX, and the country of Mexico.
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.
Code information (models, lots, serial numbers)
Lot Numbers: SFP02323, SFP02323R, and SFP02323RR
Other devices under the same FDA submission
1 device cleared under K093438 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- coflex-F LIS screw inserter RAT20222Paradigm Spine GmbH · Appliance, Fixation, Spinal Interlaminal1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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