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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00302-1
Product Name/Description	Nobel Replace Conical Connection PMC RP 5.0x13mm ( Fully Imbedded Dental Implant – Screw endosteal) Batch number: 13010296 Article number: 37298 ARTG Number: 202090
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	2/04/2015
Responsible Entity	Nobel Biocare Australia Pty Ltd
Reason/Issue	Nobel Biocare Quality Management Systems observed an issue with a material used in the packaging of the implants. The packaging component (cap) showed excessive oil which was caused by an issue in production of the raw material (pellets) for manufacturing the caps. Nobel Biocare's internal analysis has confirmed that this material is not according to the standards. Based on the testing performed so far the likelihood that the products cause adverse health consequences is currently considered to be low. The implant batches still at the manufacturing site were restricted for further distribution and placed in quarantine.
Recall Action	Recall
Recall Action Instructions	Nobel Biocare requested the customer to return the affected product with batch number 13010296. Nobel Biocare is providing a replacement product. This action was underatken prior to notifying TGA.
Contact Information	61 3 9885 5388 - Roy Hardman