| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00063-1 |
| Product Name/Description |
Dental Surgical Handpiece S-12 without light
Article number : 30061000
Serial #s: 04972; 04985 – 04989; 04990 - 04992; 04994; 04997; 04998; 05000; 05001- 05003; 05106 - 05110; 05123 - 05126; 05177; 05181; 05190 - 05196;
ARTG: 97374 - W & H Australasia Pty Ltd - Drill dental remotely driven handpiece |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/01/2024 |
| Responsible Entity |
|
| Reason/Issue |
The surgical handpieces S-12 (30061000) 1:2 speed increasing have been incorrectly laser marked during production.
The specific laser marking should read 1:2, but instead reads 1:1 on the body of the handpiece. In the worst-case scenario, this may result in excessive speed being set on the surgical unit.
W&H is not aware of any adverse events associated with the wrong laser marking. |
| Recall Action |
Recall |
| Recall Action Instructions |
W& H is initiating a recall of the affected products and will replace misbranded S-12 handpieces with correctly labeled S-12 handpieces.
Customers should quarantine and return the affected products to W& H Australia
Distributors should remove product from sale, cease distribution, sub-recall the affected products and return products to W&H Australasia Pty Ltd. for disposal. |
| Contact Information |
+61 402 318 880 - Victoria You |