FDA recall Z-2897-2018

Richard Wolf GmbH · Class II · device

Product

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.

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2017-07-24
Report date
2018-08-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Knittlingen, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2897-2018