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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