Teleflex Medical recalls ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is inte…

Recall date

November 8, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0677-2017

FDA classification

Class II

Brand / firm

Teleflex Medical

Sold / distributed

Worldwide Distribution - US (nationwide) Internationally to Brazil, Canada, Ecuador, Guatemala, Mexico and Peru.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.