FDA-Device2014-01-15Class II
PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
SpineFrontier, Inc.
Hazard
Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
Sold states
US Distribution: including states of: TX and VA.
Affected count
13 devices
Manufactured in
500 Cummings Ctr Ste 3500, Beverly, MA, United States
Products
PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0624-2014Don't want to check this manually?
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