| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00593-1 |
| Product Name/Description |
5mm Round Fluted Bur Aggressive, Round Fluted Soft Touch 3.0mm, Round Fluted Bur 6.0mm, 3mm Round Fluted Bur Aggressive, Neuro Drill 3.0mm, 6mm Round Fluted Bur Aggressive, Round Fluted Bur 1.0mm and 5.0mm Egg Bur (Orthopaedic bur used for soft tissue debridement and bone abrasion and removal)
Multiple item numbers and lot numbers affected |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
During manufacture, the notching completed on one specific machine may have been started too close to the end of the shank. In some products (approximately 1/1000), there may be missing notches, partial notches or no notches at all. The listed cutting accessories are manufactured with notches at the proximal end of the bur. The notch is a feature on the bur that is used to retain and control the exposure of the bur within the drill/attachment. The correct number of notches varies from 2 to 5, based on the specific product number. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is requesting their customers to quarantine all affected stock and advising that they will be contacted to organize for the return of the product. |
| Contact Information |
1800 803 601 - Stryker RAQA Coordinator |