Recall Z-0624-2014— SpineFrontier, Inc.

Name: FDA recall Z-0624-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-11

Class II · Terminated

Class II FDA medical device recall by SpineFrontier, Inc., initiated 2013-09-11, terminated 2014-10-08. It names one FDA 510(k) clearance: K123164. Product: PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.. Reason: Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications..

Recalling firm: SpineFrontier, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-09-11
Terminated: 2014-10-08
Firm location: Beverly, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K123164 — SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEMSpinefrontier, Inc.·cleared 2013-02-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.

Reason for recall

Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.

Data sourced from openFDA. This site is unofficial and independent of the FDA.