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

Recall Z-1973-2019 — A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)

U.S. FDA — Device Enforcement · United States · 2019-06-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1973-2019
Date of alert
2019-06-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
SpineFrontier, Inc.
Product category
device
Product type
Devices
Reported risk: There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.
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.

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