Cerabone Granules and Mucoderm (multiple sizes)
Reason for Recall / Hazard
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.
Product Description & Identification
Reason / Defects: 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. Hazards: 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 to 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.
Affected Products
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)
Additional Source Details
| Field | Value |
|---|---|
| Guid › #text | 5930e964-aee0-4858-b785-e6a098d71b76 |
| Guid › @ is Perma Link | false |
| Link | https://www.productsafety.gov.au/search-consumer-product-recalls/cerabone-granules-and-mucoderm-multiple-sizes |
| Pub Date | Wed, 08 Sep 2021 00:00:00 +0000 |