| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00852-1 |
| Product Name/Description |
T-PAL (Transforaminal Posterior Atraumatic Lumbar Cage System)
ARTG number: 153950 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
31/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer’s assessment has identified that incorrect handling of the T-PAL applicator instrument could potentially contribute to failure of the Applicator Inner Shaft (PN 03.812.003) during insertion of implants or the non-detachable T-PAL Trial implants (PN 03.812.307-.317 and 03.812.507-517). As a result, the T-PAL Technique Guide (PN 036.001.088) was updated to clarify instrument handling of the T-PAL applicator (PN 03.812.001 Applicator Outer Shaft, PN 03.812.004 Applicator Knob).
If the Inner Shaft should break, the trial (or implant) spacer will no longer be secured in the 0° position. This rigid position is necessary for insertion. If the Inner Shaft should break in the pivoting position, the assembly cannot be properly advanced into the disc space. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Synthes Australia is requesting their customers to replace the T-PAL Technique Guide with the updated version (PN 036.001.088, Version AD). This action has been closed-out on 03/06/2016. |
| Contact Information |
1800 796 8437 - Synthes Australia |