Device product
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.
Z-0790-2016
Product summary
- Event
- Event 73091
- Status
- Terminated
- Classification
- Class II
- Quantity
- four units
- Official record key
device-enforcement:Z-0790-2016
Official wording
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.
Code information: Affected lot 0207201502.
Distribution pattern: Distributed in Washington.
Derived failure modes
-
Unknown
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.