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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 Biomet 3i Australia Pty Ltd
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