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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00741-3
Product Name/Description 44R82 Tube Clamp Adapter (Prosthetic component part)

ARTG Number: 129755
Recall Action Level Retail
Recall Action Classification Class II
Recall Action Commencement Date 20/07/2012
Responsible Entity Otto Bock Australia Pty Ltd
Reason/Issue Otto Bock HealthCare GmbH has received a number of complaints that the adapters have shown signs of cracking during assembly or fitting. On two occasions cracks developed after the prosthesis was used for a short period of time.
Recall Action Recall for Product Correction
Recall Action Instructions Quarantine and return affected devices to Otto Bock Australia
Contact Information 02 8818 2824 - Otto Bock Regulatory Affairs