PedFuse Bone Probe recallZ-0624-2014 · SpineFrontier, Inc. · initiated Sep 11, 2013
Class II Terminated All recalls posted in January 2014
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
Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
FDA root cause category: Process change control
What the company is doing
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.
Recall details
- Recall number
- Z-0624-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 11, 2013
- Posted by the FDA
- Jan 3, 2014
- Recalling firm
- SpineFrontier, Inc.
- Quantity
- 13 devices
- Product code
- HXB
- FDA submissions
- K123164
- Distribution
- US Distribution: including states of: TX and VA.
Product description
PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
Code information (models, lots, serial numbers)
Lot: 012212-001
Other devices under the same FDA submission
1 device cleared under K123164 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PedFuse 01-80325Spinefrontier, Inc. · Orthosis, spinal pedicle fixation1 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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