Recall Z-0789-2016 ยท HRX Arthroscope
Richard Wolf Medical Instruments Corp.
Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
| Date | Feb 9, 2016 (initiated Nov 25, 2015) |
| Status | Terminated |
| Reason | Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional. |
| Root cause | Process control |
| Action | The firm sent an URGENT Medical Device Recall letter dated 11/25/2015 to consignees informing them of the recall and the actions needed to be taken. These included to not use the affected burr and to destroy the device. The user is also instructed to fill out the Recall Action Response Form to acknowledge receipt of the notification. The form should be scanned to Dsantostefano@richardwolfusa.com or mailed to: Dawn Santostefano, Recall Coordinator Richard Wolf Medical instruments 353 Corporate Woods Parkway Vernon Hill, IL 60061 |
| Quantity | Ten units |
| Distribution | Distributed in Washington. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984304 | RIWO DRIVE GENERATOR Richard Wolf Medical Instruments Corp., Aug 12, 1999 |