Reuseable rotary blade/abrader, product number 899751514. The oval burr frontally hooded is an attachment or accessory t
FDA device recall Z-0791-2016 · posted 2016-02-09 · Terminated
Recall details
- Recalling firm
- Richard Wolf Medical Instruments Corp.
- Reason for recall
- 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.
- Action taken
- 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
- Root cause
- Process control
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 2 units
- Distribution
- Distributed in Washington.
- Date initiated
- 2015-11-25
- Date posted
- 2016-02-09
- Date terminated
- 2017-08-21
- Location
- Vernon Hills, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RIWO DRIVE GENERATOR (K984304) | Richard Wolf Medical Instruments Corp. | 1999-08-12 |