| TGA Action ID |
RC-2025-RN-00211-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
OUTER-GRIP LOCKING FEM IMPLANT IMPACTOR
Product number: 74018902
Batch numbers: 23BCT0001, 22JCT0027, 23FCT0006, 23FCT0007, 23ACT0025, 22FCT0029, 22JCT0019, 22MCT0022, 23ECT0001, 23CCT0018, 23FCT0008 |
| ARTG Number |
101516 |
| Unique Device Identifier (UDI) |
00885556697962 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Due to a manufacturing error, there is an increased potential for the disassembly of the dowel pin and the impactor plate due to the reaming of the drive shaft pin holes.
In the most-likely scenario, the impactor remains fully assembled and performs as intended. There is no hazardous situation and no harm.
In the worst-case scenario, the pin falls out during impaction, resulting in the impactor plate and spring fully disassembling from the device which is obvious to the surgical team. If the pin disassembles and falls into the site, the pin is easily detectable due to its size and the heightened awareness of the surgical team.
In the observed complaints occurring during operation, the pin did not fall into the site. |
| Instructions for Customers/Users |
Customers may continue to use the affected device, however prior to use must inspect the instrument as required in the instructions (81103630 Rev. F, available online at https://ifu.smith-nephew.com/). The instructions state “Visually inspect for damage or wear.”
If the defect is identified do not use the device.
A Smith+Nephew Sales Representative will visit customers to remove affected devices and supply replacements. It is estimated replacement product will be available in approximately 8 weeks.
A list of alternatives products is listed in the customer letter if unaffected product is needed sooner.
Smith+Nephew recommends that physicians maintain their routine patient follow-up protocol.
This action has been finalised on 9/7/2025. |
| Action Commencement Date |
14/03/2025 |
| Responsible Entity |
|
| Contact Information |
13 13 60 - ANZ Regulatory Affairs Team |