Skip to main content

Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton DBM Orthoblend - Implant - Jar/Can, Medtronic Australasia Pty Ltd, CON-1013

Product name
Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton DBM Orthoblend - Implant - Jar/Can
Sponsor name
Medtronic Australasia Pty Ltd
Batches
T44125AUS-31 Units T44145AUS-299 Units T44150AUS-279 units
Consent start
Consent no.
CON-1013
Standard
clause 11(18) of the Therapeutic Goods (Standard for Human Cell and Tissue Products'”Donor Screening Requirements) (TGO 108) Order.
Non-compliance with standard
The products do not conform with clause 11(18) of TGO 108 that specifies that the serum or plasma of a blood sample taken from a donor of HCT materials must be retained for a minimum of two years after the expiry date of the relevant HCT product, or for a period that is validated on the basis of validated data or documented evidence from relevant scientific literature.
Therapeutic product type
Blood, tissues, and biologicals

Help us improve the Therapeutic Goods Administration site