| TGA Action ID |
RC-2025-RN-01053-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Torque Screw Component of the HFD100 Head Fixation Device
IMRIS Part Numbers: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600
Multiple device descriptions and UDI numbers |
| ARTG Number |
276862 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The torque screw component of the HFD100 Head Fixation Device, which attaches to the skull clamp assembly and provides one of three points of pinned fixation, may crack or begin to separate radially along the exterior housing. This has been reported to be observed during or immediately before clinical use.
A cracked or damaged torque screw, if used, could lead to increased risk of inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.
To date, IMRIS has received three complaints of a torque screw exhibiting cracks or breaking during advancement into the HFD100 Head Fixation Device. IMRIS has not received reports of injury associated with this problem. |
| Instructions for Customers/Users |
Customers should note that the existing torque screw component of the HFD100 Head Fixation Device will be replaced with an improved design. The correction is planned to be available starting in January 2026 and Emergo will contact customers to perform the correction at their facility.
Until the HFD100 Head Fixation Device torque screw component is replaced, customers should:
· Ensure the patient’s head is supported during pin penetration: serious patient injury may result from improper head and neck support during pin penetration of the skull for head placement.
· If a crack develops during advancement or retraction, please discontinue use and release the skull clamp halves through activating the base locking knob. Please notify Emergo.
· Prior to each device use, closely inspect the torque screw component for any signs of wear, cracking, or damage along the exterior threads.
· Handle the torque screw with care during assembly, disassembly, cleaning and storage between uses; if the torque screw is inadvertently dropped or impacted by another object, immediately discontinue use and notify Emergo.
· Ensure the instructions in the Operator Manual for proper HFD100 Head Fixation Device assembly and use are followed to produce rigid fixation.
This action has been closed out on 12/05/2026 |
| Action Commencement Date |
15/12/2025 |
| Responsible Entity |
|
| Contact Information |
AUNZvigilance@ul.com - Emergo Australia |