Medical device recalls Moderate risk

SpineFrontier, Inc. recalls lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164

Recall date
December 19, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0977-2015
FDA classification
Class II
Brand / firm
SpineFrontier, Inc.
Sold / distributed
Nationwide Distribution including TX, OH, VA, and Washington, DC.

Why it was recalled

A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164

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