| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01170-1 |
| Product Name/Description |
Zimmer NexGen Trabecular Metal Tibial (Replacement) Impactor Pad Instruments
Item Numbers: 00-5953-056-00 & 00-5953-056-06
ARTG Number: 109936 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/10/2014 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer has received complaints related to the fracture of Trabecular Metal Tibial Impactor Pad Instruments. Based on the investigation results of these complaints, Zimmer determined that the instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads require clarification to avoid fracture. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Zimmer is providing additional instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads.Users are also advised that after removal of the pads to inspect them for any cracks or damage, including any cracks around the prongs. If any of the prongs are broken, or if any cracks or damage are observed, replacement pads can be requested through Zimmer's sales representative. This action has been closed-out on 06/06/2016. |
| Contact Information |
02 9843 5400 - Zimmer Pty Ltd |