Reported Jan 15, 2014 · Terminated
PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
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?
- PedFuse Bone Probe
- PartSI81008 spinal pedicle fixation
- Lot codes and dates
- Lot012212-001
- Amount recalled
- 13 devices
Where it was sold
Why it was recalled
Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
This product could cause temporary or reversible health problems — stop using it.
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