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Terminated

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

FDA Recall Z-1973-2019 · Posted None

Recalling FirmSpineFrontier, Inc.
Recall StatusTerminated
Product CodeOVE
Date Initiated2019-06-13
Date Terminated2020-05-11
Product Quantity6

Reason for Recall

There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.

Firm Action

Urgent Medical Device Recall letters dated 6/13/19 were emailed to customers.

Root Cause

Process control

Distribution Pattern

The products were distributed to the following US states: AZ, MD, MO, and FL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172484A-CIFT SoloFuseSpinefrontier, Inc. · 2018-05-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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