Reuseable rotary blade/abrader, product number 899751504. The oval burr laterally hooded 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.
Recall
- Recall Number
- Z-0790-2016
- Event Number
- 73091
- Firm
- Richard Wolf Medical Instruments Corp.
- FEI Number
- 1418479
- Product Code
- HRX
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- November 25, 2015
- Posted
- February 9, 2016
- Terminated
- August 21, 2017
- Address
- 353 Corporate Woods Pkwy, Vernon Hills, IL, 60061-3110
Description
Reuseable rotary blade/abrader, product number 899751504. The oval burr laterally hooded 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.
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.
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 [email protected] or mailed to: Dawn Santostefano, Recall Coordinator Richard Wolf Medical instruments 353 Corporate Woods Parkway Vernon Hill, IL 60061
Distributed in Washington.
four units