Type of Product |
Medical Device |
TGA Recall Reference |
RC-2024-RN-00353-1 |
Product Name/Description |
OXINIUM FEMORAL HEAD 12/14 32MM +4
Batch Number: 23FM03219
Product Number: 71343204
UDI: 03596010474223
ARTG: 218140 (Smith & Nephew Pty Ltd - OXINIUM Femoral Heads 12/14 Taper - Ceramic femoral head prosthesis) |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
7/05/2024 |
Responsible Entity |
|
Reason/Issue |
A complaint was received indicating that a package contained an OXINIUM FEM HD 12/14 36 MM M/+4 implant instead of an OXINIUM FEM HD 12/14 32MM +4 as described on the product label. |
Recall Action |
Recall |
Recall Action Instructions |
Customers are to: - Locate and quarantine unused affected devices immediately. - Return quarantined product to their Smith+Nephew agency/distributor. - If impacted batches have been implanted, maintain the routine patient follow up protocol.
This action has been finalised on 25/6/2024. |
Contact Information |
0408 067 509 - Sahil Talwar, Principal RA Specialist |