PRA number
Published date
Product description
Cerabone Granules (multiple sizes) and
Mucoderm (multiple sizes)
Product numbers: BO-1510, BO-1511, BO-1512, BO-1515, BO-1520, BO-1521, BO-1522, BO-1525, BO-701520, BO-702030 and BO-703040
All lot numbers supplied since 1 December 2020
ARTG 329433
(Straumann Pty Ltd - cerabone granulate - Dental bone matrix implant, animal-derived)
ARTG 353073
(Straumann Pty Ltd - mucoderm - Collagen dental regeneration membrane)
Reasons the product is recalled
The product's patient information leaflet and patient implant card have been left out when the products were supplied.
The implantation card and patient information sheet provide traceability of the products and important safety information for the patient.
The hazards to consumers
Patients who have been supplied the products without the correct patient information, may not be aware of important information about the use of the product and this poses an increased risk of adverse health complications.
What consumers should do
Consumers will be contacted by Straumann and provided with an updated patient implant card and patient information leaflet.
For more information, contact Straumann on 03 9261 1300.
Supplier
Traders who sold this product
Hospitals and dental care centres
Where the product was sold
Dates available for sale
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.