| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00316-1 |
| Product Name/Description |
Trumpf Table Top Spinal System (T3SYSTEM)
Manufacturing Dates: March 2009 to November 2016
ARTG Number: 252619
(Trumpf Med Aust - Table, operation) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
Allen Medical has become aware that the rail section clamps used to attach the Leg Support of the T3 Trumpf Table may fail during use, which could result in critical harm to the patient. The T3 Trumpf Table Top Rail Section Clamps, F-T3RAILSC, are designed and labelled for use with armboards only but were shipped to be used with the Leg Support. The Instructions for Use (D-720595-A3) incorrectly guides the user to connect the Top Rail Section Clamp to the Leg support.
Three complaints without any allegation of injury have been reported since introduction in September 2009. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Trumpf are advising users to ensure that the T3 Trumpf Table Top Rail Section Clamps are used with armboards only. Users should inspect beds and remove any clamps currently in use with the Leg support.
Allen Medical will be providing users with new Rail Section Clamps along with revised Instructions for Use. These are expected to be available by May 2018.
This action has been closed out on 01/08/2019 |
| Contact Information |
1800 445 476 - Trumpf Medical Technical Support |