| 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 |