Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2092-2014 — 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).

U.S. FDA — Device Enforcement · United States · 2014-06-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2092-2014
Date of alert: 2014-06-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Alphatec Spine, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-2092-2014 — 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).

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