| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01387-1 |
| Product Name/Description |
Hallu-Fix Drill, Diameter 1.9mm, supplied in Hallu-Fix system instrumentation set (used for orthopaedic foot surgery)
Catalogue Number for Drill: 119618ND
Lot Number: FE58
ARTG Number: 174104 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has identified a defect in lot FE58 of Hallu-Fix Drill Diameter 1.9mm, where the drill may not be sharp enough to prepare screw holes. The defect can be easily recognised during use and an increase of surgery time may be observed while another similar drill is found to prepare the screw holes. If an affected drill is used, the defect can contribute to an increase of surgery time of approximately 10 minutes and require a higher pressure on the drill. This pressure may cause minimal transient tissue damage and difficulties to achieve the surgery. To date no injury or adverse event has been reported. |
| Recall Action |
Recall |
| Recall Action Instructions |
Integra Neurosciences is advising customers to review their inventory for the affected drill and stop using the affected drill immediately. Integra will provide directions for return of the product and will replace affected stock. This action has been closed-out on 18/05/2017. |
| Contact Information |
1300 550 599 - Integra Customer Service |