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