| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01543-1 |
| Product Name/Description |
Straumann dental surgical drills
Drill 1, short, Ø 2.2mm, l 33.0mm, SS
Article #: 044.210
Lot #: MG783
Component # Number (on drill): LZ239
Twist Drill PRO Ø4.2mm,long,41mm,SS
Article #: 044.255
Lot #: LV455
Component Lot # (on drill): LF828
ARTG Number: 119314 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/11/2016 |
| Responsible Entity |
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| Reason/Issue |
The investigation of a received complaint has confirmed that the shaft diameter of a drill article number 044.215 lot LV457 is greater than the defined specification of ø2.35mm in the area of the laser marking on the shaft. Further investigation has shown that the further articles and lots are also impacted. Testing with different handpieces shows that the drills can be inserted. However, depending on the manufacturing tolerances of the handpiece that is used, these drills may not fit. If the drills do not fit into the handpiece and there is not an alternative instrument available, then the the planned treatment would need to be re-scheduled. |
| Recall Action |
Recall |
| Recall Action Instructions |
Straumann has advised customers to check their inventory for affected product and return all stock. Straumann will provide replacements. This action has been closed-out on 09/06/2017. |
| Contact Information |
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