| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01210-1 |
| Product Name/Description |
Kirschner Wire 1.6 mm, with drill tip, length 200 mm
Part Number: 02.113.001
All Lot Numbers affected
ARTG Number: 203638 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
16/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
The Kirschner wire is made from Co35Ni35Cr20Mo10 (MP35N) which is cobalt based alloy containing 35% nickel. However, the label and technique guide incorrectly indicate that the devices are made of stainless steel.
The product is shipped with an insert which references the potential risk of allergy/hypersensitivity reactions, but there is no specific information on the label or in the technique guide with regards to the percentage of nickel content in the devices.
Although unlikely, there is a potential for surgeons to use the affected products on patients with a nickel allergy, which could lead to an allergic reaction. As MP35N is a more corrosion-resistant alloy and more biocompatible than stainless steel, the likelihood of a patient being exposed and sensitised to a higher amount of nickel or other alloys is low compared to a product manufactured from stainless steel. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The sponsor is advising users to review the instructions listed in the customer letter. Users are not requested to return the product. |
| Contact Information |
1800 252 194 - JJM |