Recall Z-2897-2018 ยท HRX Arthroscope
Richard Wolf GmbH
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.
| Date | Jul 24, 2017 |
| Status | Open, Classified |
| Reason | Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury. |
| Root cause | Process control |
| 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 |
| Quantity | 12 units |
| Distribution | Worldwide distribution to Germany, Hong Kong, Ireland, Romania, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953868 | GRASPING FORCEPS, BIOPSY FORCEPS, SCISSORS, PUNCH Richard Wolf Medical Instruments Corp., Sep 29, 1995 |