| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00917-1 |
| Product Name/Description |
Neoss Guide – Drill-Hubs I to V included in Neoss
Guide Kit Ø3.5 - Ø4.5 (art no 51153)
Identifier #9040
Batch Number: 15182, 15586, 16030
ARTG Number: 119446 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
These batches of Drill-Hub I may not be functioning as intended (drill does not latch completely in the Drill-Hub I).
The upper part of the bore in the Drill-Hub I is slightly smaller which results in the drill not being seated correctly which means that this Drill-Hub will drill deeper than intended, this could lead to permanent damage of the alveolar nerve and cause permanent loss of sense in parts of the oral cavity or chin or even partial loss of speech. There is also a risk of drill loosening or not rotating as expected.
No incidents have been reported in Australia. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are asked to inspect their stock on hand and to quarantine affected units prior to their return to Neoss as per the instructions in the Customer Letter. |
| Contact Information |
07 3216 0165 - Neoss Australia |