| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00021-1 |
| Product Name/Description |
Comprehensive Reverse Shoulder Tray
Item Number: 115340
Lot Numbers: 132030, 172670, 310620, 367330, 482000, 558910, 648860, 950390
ARTG Number: 263033 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
A higher than anticipated fracture rate has been identified for certain lots of the Comprehensive Reverse Shoulder Trays manufactured prior to September 2011. Devices manufactured after this date have design enhancements that increased the strength of the device. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Zimmer Biomet is advising surgeons to monitor patients through regular consultations to determine the need for any treatment. This action has been closed-out on 07/09/2018. |
| Contact Information |
02 9483 5426 - Zimmer Biomet |