Richard Wolf GmbH recalls Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue vi…

Recall date

July 24, 2017

Source

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

Recall number

Z-2897-2018

FDA classification

Class II

Brand / firm

Richard Wolf GmbH

Sold / distributed

Worldwide distribution to Germany, Hong Kong, Ireland, Romania, and Turkey.

Why it was recalled

Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury.

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

What was recalled

Artholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages. Product Usage: Device is a standard punch; standard punches are used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages.