Z-1479-2015 Class II Terminated
FDA device recall Z-1479-2015 was initiated by SpineFrontier, Inc. on Mar 5, 2015 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Jun 15, 2015). Affected quantity: 5 devices.
Recall details
- Product Type
- Devices
- Report Date
- Apr 29, 2015
- Initiation Date
- Mar 5, 2015
- Termination Date
- Jun 15, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 devices
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.
Reason for recall
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.
Distribution pattern
US Nationwide Distribution in the states of TX, KS, CO, and MA
Code information
Revision E
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1479-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026