Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton DBM Flex - Medtronic Australasia Pty Ltd - Implant - Pouch, Medtronic Australasia Pty Ltd, CON-1010
Product name
Musculoskeletal Tissue - Bone, morsellised, demineralised - L - Grafton DBM Flex - Medtronic Australasia Pty Ltd - Implant - Pouch
Sponsor name
Medtronic Australasia Pty Ltd
Batches
T42100AUS - 17 units T42110AUS - 26 units
Consent start
Consent no.
CON-1010
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