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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