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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00013-1
Product Name/Description	Persona (TASP) Tibial Articular Surface Provisional Shim All sizes and lots Catalogue Number: 42-5279-003-00 thru 42-5279-009-04 ARTG number: 109936
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	15/01/2015
Responsible Entity	Zimmer Pty Ltd
Reason/Issue	Zimmer is initiating this Recall due to Provisional Shims being found with missing ball bearings. Zimmer’s investigation has found that repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim. This gives rise to the potential for delays in surgery and/or a missing part from the device being left in the wound. This issue was also identified following worn returns being reported through the worn instrument program. No complaints from Australia have been received regarding this issue.
Recall Action	Recall for Product Correction
Recall Action Instructions	Customers are requested to inspect any product referenced within this notification before and after use for missing ball bearings and to provide any devices with missing ball bearings to your Zimmer sales representative for return. This action has been closed-out on 18/03/2016.
Contact Information	02 9483 5400 - Zimmer Pty Ltd