| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00306-1 |
| Product Name/Description |
CUSA Excel+ Sterile Torque Disposable Wrench (23kHz)
Catalogue Number: C5601
Lot Numbers: 1132424, 1132883, 1132884, 1133453, 1133454, 1133455, 1134067, 1134675, 1134873, 1135014
ARTG Number: 151 502 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
Integra LifeSciences has identified that some lots of 23 KHz Sterile Torque Wrenches contain wrenches that will only fit 36 KHz CUSA handpiece tips. The green colour code and size printed on the wrenches are correct for a 23 KHz wrench, but the affected wrench size insert is smaller than it should be and will only fit a 36 KHz CUSA tip. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Integra is requesting end users to determine if they have any units from the affected lot. If the outer box has a green dot sticker the torque wrench can be used. If the box does not have a green dot sticker end users are requested to quarantine the unit. An Integra sales representative will arrange for the affected units to be inspected. In the event that an inspection cannot be undertaken in a reasonable time replacement units will be arranged. |
| Contact Information |
1300 550 599 - Integra Customer Service |