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.
- Recall Initiated
- July 24, 2017
- Recall Number
- Z-2897-2018
- Quantity
- 12 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.
Distribution
Worldwide distribution to Germany, Hong Kong, Ireland, Romania, and Turkey.
Lot / Code Info
Product Number 89140.0105, Lot Number 4500197481
Root Cause
Process control
Action Taken
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