| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00315-1 |
| Product Name/Description |
X Series Power System Double Trigger Handpiece
Item number: 89-8520-400-00
Multiple item numbers, lot numbers, serial numbers and UDI numbers
ARTG 215808
(Zimmer Biomet Pty Ltd - Drill, surgical, battery powered, motor) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer Biomet Pty Ltd has identified two problems with certain serial numbers of the X Series Power System Double Trigger Handpiece.
The first problem is a potential failure of the X Series Double Trigger handpiece locking mechanism. The second problem is due to potential cracking of the plastic rear cap.
Both problems may lead to an extension of surgery time. The affected units were distributed between May 2021 and October 2022. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to return any affected stock to Zimmer Biomet who will carry out the upgrades. The handpieces will then be returned to customers once the upgrade is complete. |
| Contact Information |
0437 628 170 - Matthew Andrew |