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.
FDA Recall Z-2897-2018 · Posted None
Recalling FirmRichard Wolf GmbH
Recall StatusOpen, Classified
Product CodeHRX
Date Initiated2017-07-24
Product Quantity12 units
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.
Firm Action
The firm notified customers on about 07/24/2018 via a Urgent safety information letter. Customers were instructed to check inventory for the affected device, return the product to Richard Wolf GmbH, and complete and return the response form. The letter also instructed customers to ensure all users in their organization are notified of the recall and to notify customers if the product was further distributed.
Safety-related questions can be directed to: Tel.: 0049 7043 35 1013
Questions concerning handling can be directed to: Technical Service Dpt., Tel.: 0049 7043 35 1046
Root Cause
Process control
Distribution Pattern
Worldwide distribution to Germany, Hong Kong, Ireland, Romania, and Turkey.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.