| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01048-1 |
| Product Name/Description |
TPS MicroDriver (used for surgical procedures involving drilling, reaming, driving wires or pins, cutting bone and hard tissue)
Catalogue Number: 5100088000
Lot Numbers: 0921700523, 0723606673
ARTG Number: 139725 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
Two batches of silicone potting have been identified by the supplier as having cure properties that were outside of the specified range. The potting material is used to insulate, stabilise and provide a moisture barrier to the main Printed Circuit Board Assembly (PCBA) of the TPS MicroDriver. Inadequate curing of the silicone potting creates the possibility for silicone potting to leak outside of the handpiece and cause electrical malfunction. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is requesting users to inspect and quarantine devices from the affected lot numbers. Affected devices are to be returned to Stryker for repair before returning to the customers. Stryker will provide a loan unit to be used until the device is repaired. |
| Contact Information |
02 9647 1214 - Stryker Regulatory Affairs |