| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00509-1 |
| Product Name/Description |
Tapered Screw-Vent Implants with 0.5 mm Machined Collar, MTX Surface and Microgrooves
Part Number: TSVM4B10
Lot Number: 63781164
ARTG Number: 126088
(Biomet 3i Australia Pty Ltd - Dental implant, endosseous) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer Biomet has identified a single lot of Tapered Screw-Vent Implants that were inadvertently packaged with patient chart labels which incorrectly indicate TSVB10 Lot Number 63773888. All outer and inner labels are correct. |
| Recall Action |
Recall |
| Recall Action Instructions |
For unused product, Zimmer Biomet is advising customers to return affected product.
For implanted devices, Zimmer is advising customers to update patient records with the correct part and lot number.
This action has been closed out on 17/10/2018 |
| Contact Information |
1800 802 457 - Zimmer Biomet |