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TGA Action ID	RC-2026-RN-00619-1
Type of Product	Medical Device
Product Name/Description	Remplir Model: ON-203 Batch/Lot: C25012A05
ARTG Number	385752
Unique Device Identifier (UDI)	09358206000050
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class III
Reason for the Action	It has been identified that a batch of Remplir devices did not include the required printed Australian Instructions for Use (IFU-0000125) and Australian Patient Implant Cards (PIN-0001140) in each individual box. Patient Billing and Implant Labels were supplied on the device packaging, which contain essential device information including the UDI, lot number, and expiry date.
Instructions for Customers/Users	Orthocell will provide the Patient Implant Cards to distributors. Hospitals are to: - Be aware that an electronic copy of the Instructions for Use (IFU) can be accessed via the QR code on the products. - Contact their distributor to request a copy of the Patient Implant Card.
Action Commencement Date	17/08/2026
Responsible Entity	Orthocell Ltd
Contact Information	08 9360 2888 - Orthocell