Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).
Reported: July 30, 2014 Initiated: June 26, 2014 #Z-2092-2014
Product Description
Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).
Reason for Recall
Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid from its fixed position during use.
Details
- Recalling Firm
- Alphatec Spine, Inc.
- Units Affected
- 14 units total (12 units in US)
- Distribution
- Nationwide Distribution including CT, NC, AL, WV, IL, AR, and NY.
- Location
- Carlsbad, CA
Frequently Asked Questions
What product was recalled? ▼
Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).. Recalled by Alphatec Spine, Inc.. Units affected: 14 units total (12 units in US).
Why was this product recalled? ▼
Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid from its fixed position during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 30, 2014. Severity: Moderate. Recall number: Z-2092-2014.
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