PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
FDA Recall Z-0624-2014 · Posted 2014-01-03
Recalling FirmSpineFrontier, Inc.
Recall StatusTerminated
Product CodeHXB
Date Initiated2013-09-11
Date Terminated2014-10-08
Product Quantity13 devices
Reason for Recall
Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
Firm Action
On 9/13/2013, consignees were notified of the recall via email. They were asked to return the recalled product and complete and return the recall acknowledgement form via email or fax.
Root Cause
Process change control
Distribution Pattern
US Distribution: including states of: TX and VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.