FDA Medical Device Recalls (openFDA)
SpineFrontier, Inc.: 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
- Recalling firm
- SpineFrontier, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2012-08-28
- Posted
- 2012-11-21
- Terminated
- 2015-06-11
- Reason
- Inspan Compressors may break at weld causing a loss of compression
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 17 units
- Distribution
- Worldwide Distribution-USA (nationwide) including PR and the states of FL, MA, MO, OK, and TX, and the country of Mexico.
- Lot, serial or model codes
- Lot Numbers: SFP02323, SFP02323R, and SFP02323RR
- 510(k) numbers
- ["K093438"]
- PMA numbers
- not on file
- Product code
- KWP
- Firm FEI
- 3005977257
- Firm city
- Beverly
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28