FDA Medical Device Recalls (openFDA)
SpineFrontier, Inc.: A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
- Recall number
- Z-1973-2019
- Recalling firm
- SpineFrontier, Inc.
- Product
- A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
- Status
- Terminated
- Initiated
- 2019-06-13
- Posted
- not on file
- Terminated
- 2020-05-11
- Reason
- There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.
- Root cause
- Process control
- Action
- Urgent Medical Device Recall letters dated 6/13/19 were emailed to customers.
- Quantity
- 6
- Distribution
- The products were distributed to the following US states: AZ, MD, MO, and FL.
- Lot, serial or model codes
- Lot EC20
- 510(k) numbers
- ["K172484"]
- PMA numbers
- not on file
- Product code
- OVE
- Firm FEI
- 3005977257
- Firm city
- Malden
- 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