FDA Medical Device Recalls (openFDA)
SpineFrontier, Inc.: PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
- Recall number
- Z-0624-2014
- Recalling firm
- SpineFrontier, Inc.
- Product
- PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
- Status
- Terminated
- Initiated
- 2013-09-11
- Posted
- 2014-01-03
- Terminated
- 2014-10-08
- Reason
- Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
- Root cause
- Process change control
- Action
- On 9/13/2013, consignees were notified of the recall via email. They were asked to return the recalled product and complete and return the recall acknowledgement form via email or fax.
- Quantity
- 13 devices
- Distribution
- US Distribution: including states of: TX and VA.
- Lot, serial or model codes
- Lot: 012212-001
- 510(k) numbers
- ["K123164"]
- PMA numbers
- not on file
- Product code
- HXB
- 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