CLASS II Device recall · Reported 29 Apr 2015 · FDA Enforcement Report
MISquito Percutaneous Pedicle Screw System Surgical Technique recalled
SpineFrontier is recalling SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique, distributed nationwide in the US. The recall was initiated on 5 Mar 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1479-2015
- FDA event ID
- 70488
- Recalling firm
- SpineFrontier, Beverly, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Mar 2015
- FDA classified
- 21 Apr 2015
- Reported
- 29 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Spinal Implants
Timeline
| 5 Mar 2015 | Recall initiated by company | |
| 21 Apr 2015 | Classified by FDA | +47 days |
| 29 Apr 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution in the states of TX, KS, CO, and MA
Nationwide ColoradoKansasMassachusettsTexas
Stores named: Walmart
Questions about this recall
Is MISquito Percutaneous Pedicle Screw System Surgical Technique recalled?
Yes. SpineFrontier recalled MISquito Percutaneous Pedicle Screw System Surgical Technique on 5 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-1479-2015.
Why was it 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.
Which lots are affected?
Revision E
Where was it sold?
US Nationwide Distribution in the states of TX, KS, CO, and MA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from SpineFrontier
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | A-cift SoloFuse Fixed Angle Driver recalled by SpineFrontier | SpineFrontier | Other | 4 states |
| Device | CLASS II | lnline Persuader- PedFuse Pedicle Screw System recalled by SpineFrontier | SpineFrontier | Device Malfunction | Nationwide |
| Device | CLASS II | S-Lift Lock Shaft Inserter, an instrument used recalled by SpineFrontier | SpineFrontier | Sterility | Nationwide |
| Device | CLASS II | Arena-L 38x28Trial Head I 10¿ Lordotic recalled by SpineFrontier | SpineFrontier | Foreign Material | VA |
| Device | CLASS II | Arena-L Trial Handle recalled by SpineFrontier | SpineFrontier | Foreign Material | VA |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |