| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01243-1 |
| Product Name/Description |
Zimmer Trabecular Metal Reverse Shoulder System Glenosphere & Base Plate (Total shoulder replacement prosthesis)
Item Numbers: 00-4349-036-11, 00-4349-038-11, & 00-4349-040-11
ARTG Number: 94829 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer has received 90 complaints related to the glenosphere disassociating from the base plate or difficulty assembling the glenosphere to the base plate. This represents a complaint rate of approximately 0.27% since the product was introduced. Based on the investigation of these complaints, Zimmer determined that additional instructions specific to the assembly of the glenosphere to the base plate were necessary in order to emphasise important techniques. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Zimmer is providing updated surgical technique guide and a link to an instructional video for users. |
| Contact Information |
1800 803 263 - Zimmer Customer Service |