PedFuse Reset Screw recallZ-0544-2014 · SpineFrontier, Inc. · initiated Oct 18, 2013
Class II Terminated All recalls posted in December 2013
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
During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity.
FDA root cause category: Software design (manufacturing process)
What the company is doing
SpineFrontier sent an Voluntary Recall Notification dated November 5,2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. All affected implants are to be returned to SpineFrontier for inspection. SpineFrontier is requiring confirmation that you have received this notice and that you will initiate the immediate return of the implants listed above. IMMEDIATE RESPONSE REQUIRED. Please feel free to contact us at 978-232-3990 Monday through Friday 8:30AM to 5:30PM EST with any questions
Recall details
- Recall number
- Z-0544-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 18, 2013
- Posted by the FDA
- Dec 19, 2013
- Recalling firm
- SpineFrontier, Inc.
- Quantity
- 35 Devices
- Product code
- MNI
- FDA submissions
- K123164
- Distribution
- US Distribution to VA and TX.
Product description
PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
Code information (models, lots, serial numbers)
Lot/Serial Numbers: 357305-000
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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