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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01013-1
Product Name/Description	Cemented resurfacing patellar implant, Ø 33mm and 36mm Cemented resurfacing patellar implant - Ø 33mm Reference Number: 1-0200833 Batch Number: 236419 Cemented resurfacing patellar implant - Ø 36mm Reference Number: 1-0200836 Batch Number: 236412 ARTG Number: 216375
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	15/08/2016
Responsible Entity	Amplitude Australia Pty Ltd
Reason/Issue	It has been reported to Amplitude that sealing of some pouches is not as resistant as intended and could compromise their integrity, resulting in non-sterile devices. This may increase the risk of post-operative infection and may lead to an increased surgical time to locate an alternative device.
Recall Action	Recall
Recall Action Instructions	Amplitude is advising users to inspect stock and quarantine the affected batches for return. This action has been closed-out on 10/05/2017.
Contact Information	08 8297 9901 - Amplitude Australia