Recall Z-0677-2017— Teleflex Medical

Name: FDA recall Z-0677-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-08

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2016-11-08, terminated 2019-11-20. It names one FDA 510(k) clearance: K113872. Product: ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.. Reason: Sterility: Due to a potential incomplete seal on the outer sterile package..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2016-11-08
Terminated: 2019-11-20
Firm location: Research Triangle Park, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K113872 — THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACAREVidacare Corporation·cleared 2012-03-08

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

ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.

Reason for recall

Sterility: Due to a potential incomplete seal on the outer sterile package.

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