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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00093-1
Product Name/Description Beaver 4.0mm Banana Blade

Model Number: 72203307

Various Batch Numbers affected

ARTG Number: 140406
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 22/01/2016
Responsible Entity Smith & Nephew Pty Ltd
Reason/Issue A number of customer complaints have been received indicating that during arthroscopic hip surgery the blades are experiencing brittle fracture.

In the event the Instrument breaks, the failure is visually obvious to the user and the broken blade can be retrieved. In a rare instance the device could break and fall into surgical site or joint space, making it difficult to retrieve. This can potentially cause a surgical delay. It has also been reported that in rare cases the broken blade remained in the patient.
Recall Action Recall
Recall Action Instructions Smith & Nephew is advising users to immediately discontinue the use of the affected units prior to their quarantine and return.
Contact Information 02 9857 3908 - Smith & Nephew