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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