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SpineFrontier, Inc. recalls PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
Recalled January 15, 2014 · FDA recall Z-0624-2014 · SpineFrontier
Hazard
Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications. · FDA Class II
Units
13 devices
Sold at
US Distribution: including states of: TX and VA.
Description
Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
Product
PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
Manufacturer(s)
SpineFrontier, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →