| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00877-1 |
| Product Name/Description |
Guide Sleeve, yellow for Trochanteric Fixation Nail Advanced (TFNA) Proximal Femoral Nailing System
Part Number: 03.037.017
Lot Numbers: 9066435, 9469298, 9542486, 9734863, 9763550, 9768881, 9768882, 9768884, 9768886
ARTG Number: 153950 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
The affected lots of the Guide Sleeves (Part # 03.037.017) may have been manufactured with a slightly larger than specified outer diameter which could prevent the sleeve from going through the Trochanteric Fixation Nail Advanced (TFNA) aiming arm properly.
In the event that Guide Sleeve does not fit through the TFNA aiming arm properly, a surgical delay may occur. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
JJM DePuy Synthes is advising users to locate any potentially affected devices in their facility, and contact their JJM DePuy Synthes representative. The representative will conduct functional testing on all products subject to this notification to determine whether the device is conforming or not. Users should ensure every aiming arm is tested with every guide sleeve within their control and, upon completion, only return the device if the product does not pass the functional test. |
| Contact Information |
1300 562 711 - JJM Customer Service |