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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01176-1
Product Name/Description Replace Select Tapered TiU RP 4.6x16mm (fully imbedded dental implant)

Product Number: 29415

Lot Number: 748046

ARTG Number: 97386
Recall Action Level Retail
Recall Action Classification Class III
Recall Action Commencement Date 23/11/2012
Responsible Entity Nobel Biocare Australia Pty Ltd
Reason/Issue Nobel Biocare Australia's quality management systems have detected that some implants from the affected lot number of the Replace Select Tapered TiU RP 4.3x16mm implant may not have been machined correctly, causing the implant driver not to be able to engage the implant. There is no expected risk as the device cannot be implanted if the defect is present.
Recall Action Recall
Recall Action Instructions Quarantine and return affected products for replacement stock.
Contact Information 1800 804 597 - Nobel Biocare Customer Service