| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01033-1 |
| Product Name/Description |
Zimmer Persona Tibial Articular Surface Provisional (TASP) Instruments
(Supplied as part of the reusable surgical kit used to aid the surgeon in assessing the thickness of articular surface required)
Multiple part (item) numbers
ARTG number: 109936 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer has received complaints related to the fracture of Persona Tibial Articular Surface Provisional (TASP) Tops and Bottoms. Based on the investigation results of these complaints, Zimmer determined that updates to device labelling associated with the Zimmer Persona Knee System were required to provide additional clarifications relating to the instructions for use of the TASP construct. . |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Zimmer is advisingthat the updated technique for use of the TASP construct and its components can be found on pp. 34-37 of the Persona Surgical Technique (97-5026-001-00, Rev. 8) which includes:
• Apply gentle manual pressure without impacting the TASP construct with either a mallet or hand. The TASP construct includes the TASP top, bottom, shim, and Tibial Sizing Plate Handle.
• During assembly of the TASP construct, slide the shim in using a direct anterior approach between the TASP top and bottom. To avoid inadvertent separation, maintain slight pressure between the TASP top and bottom while inserting the shim.
• Varus/Valgus forces may make it difficult to remove the TASP construct. To aid in the removal of the TASP and prevent breakage, ensure that the joint is in a neutral position when removing the TASP construct. This action has been closed-out on 18/03/2016. |
| Contact Information |
1800 803 263 - Zimmer Customer Service |