Reported Jan 21, 2015 · Terminated
lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
SpineFrontier, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SpineFrontier, Inc. · 500 Cummings Ctr Ste 3500 · Beverly, MA · 01915-6516
Is this the product you have?
- lnline Persuader- PedFuse Pedicle Screw System
- Part Number11-80164
- Lot codes and dates
- Lot/Serial Numbers
06440-000006441-0000AG24
- Lot/Serial Numbers
- Amount recalled
- 4 devices
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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