Cerabone Granules and Mucoderm (multiple sizes)
Published 8 September 2021
Product
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)
Why it was 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.
Hazard
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.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.