SpineFrontier MISquito Percutaneous Pedicle Screw System… recallZ-1479-2015 · SpineFrontier, Inc. · initiated Mar 5, 2015
Class II Terminated All recalls posted in April 2015
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
The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use of the design.
FDA root cause category: Labeling design
What the company is doing
SpineFrontier sent an Urgent Advisory Notice letter to customers via email. The letter identified the affected product, problem and actions to be taken. Customers were asked complete and return the Acknowledgement Form to confirm receipt of the recall notification. For questions call 978-232-3990.
Recall details
- Recall number
- Z-1479-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 5, 2015
- Posted by the FDA
- Apr 21, 2015
- Recalling firm
- SpineFrontier, Inc.
- Quantity
- 5 devices
- Product code
- FTY
- FDA submissions
- K123164
- Distribution
- US Nationwide Distribution in the states of TX, KS, CO, and MA
Product description
SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally invasive surgical (MIS) technique of posterior pedicle screw fixation.
Code information (models, lots, serial numbers)
Revision E
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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