Alphatec Spine Recalls Solanas 2.1mm Fixed Depth Drill
Alphatec Spine is recalling 14 units of the Solanas 2.1mm Fixed Depth Drill because the golden stop slid from its fixed position during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device malfunction during use where the safety stop failed, representing a risk of harm to patients, but no injuries or illnesses have been reported.
Plain-English summary
Alphatec Spine, Inc. is recalling the Solanas 2.1mm Fixed Depth Drill, 10mm (Part No. 63928-10). This instrument is a 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). The recall covers 14 units total, with 12 units distributed in the United States.
The recall was initiated after the manufacturer received a report that the instrument malfunctioned during use. Specifically, the golden stop slid from its fixed position. The affected units are identified by Lot No. 7117902.
The product was distributed nationwide, including in Connecticut, North Carolina, Alabama, West Virginia, Illinois, Arkansas, and New York. The source text does not report any illnesses or injuries associated with this malfunction.
The recalled product
- Product
- 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).
- Manufacturer
- Alphatec Spine, Inc.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot No. 7117902
Distribution
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