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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01413-1
Product Name/Description	Signature Orthopaedics Logival 20 degree Hooded XLPE Liner (Hip Replacement Prosthesis, Acetabular Component) Catalogue Numbers: 111-12-0250, 111-12-0660, 111-12-0652, 111-12-0656 Batch Numbers: 77FAE, 78320, 78347, 7739B, 78334, 7739C-1 ARTG Number: 277875 (Signature Orthopaedics Pty Ltd - Logical XLPE Liner - Non-constrained polyethylene acetabular liner)
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	15/11/2017
Responsible Entity	Signature Orthopaedics Pty Ltd
Reason/Issue	Signature Orthopaedics is recalling the affected batches of the Logical 20 degree Hooded XLPE Liner. The batch numbers are displayed on the product labels. These devices are not intended for the market in Australia, and had been distributed following a logistical error. There is no risk to patient safety as a result of this issue.
Recall Action	Hazard Alert
Recall Action Instructions	Signature Orthopaedics is advising users to inspect stock and quarantine any remaining units from the affected batches. There is no additional safety risks or follow up required for implanted devices. This action has been closed out on 31/10/2018
Contact Information	02 9428 5181 - Signature Orthopaedics