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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01124-1
Product Name/Description BioPlant Curved Syringe, multiple doses, BioPlant Intro Pack (synthetic dental bone grafts)

BioPlant Curved Syringe 0.125g
Part Number: 216110

BioPlant Curved Syringe 0.25g
Part Number: 216112

BioPlant Curved Syringe 0.50g
Part Number: 216114

BioPlant Curved Syringe 0.25g (2 pack)
Part Number; 216132

BioPlant Intro Pack
Part Number: 216112B

(Synthetic dental bone grafts)

All production lots within shelf life

ARTG Number: 121686
Recall Action Level Retail
Recall Action Classification Class II
Recall Action Commencement Date 5/11/2012
Responsible Entity Kerr Australia Pty Ltd
Reason/Issue It has come to the attention of Kerr Australia that disturbing the BioPlant product soon after it is placed may halt or delay the ossification process.
Recall Action Recall for Product Correction
Recall Action Instructions Update to Instructions for Use (IFU).
Contact Information 1800 643 603 - Kerr Australia Customer Care