Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00892-1
Product Name/Description Equinoxe Reverse Compression Screws, Replicator Plates, Locking Screws, Compression Screw Kit, Fracture Adapter Tray Screws and Octane-C Intervertebral fusion devices (intended for Primary and Reverse Total Shoulder joint Arthroplasty)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 5/09/2012
Responsible Entity Exactech Australia
Reason/Issue The device labelling identifies the affected parts as having a ten year shelf life, however the packaging configuration that was used qualifies it as a five year shelf life.

This recall action was not notified to the TGA before it was initiated by Exactech Australia.
Recall Action Recall
Recall Action Instructions Cease sale, use and further distibution of the affected products and return the stock to Exactech Australia.
Contact Information 02 9889 4663 - Exactech Australia