| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00337-1 |
| Product Name/Description |
Paragon Stem Standard Collared Size 7 / Paragon Stem High Offset Size 8
Part Numbers: GM08001-201-07 / GM08001-202-08
Lot Numbers: 536023 / 536015
ARTG 296134
(Corin Australia Pty Ltd - Paragon Hip System Collared Stem PCHA - Press-fit hip femur prosthesis, one-piece)
ARTG 296139
(Corin Australia Pty Ltd - Paragon Hip System Femoral Stem PCHA, Collarless, Uncemented - Press-fit hip femur prosthesis, one-piece) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
A Paragon Stem High Offset Size 8 Lot # 536015 was incorrectly labelled and packaged as a Paragon Stem Standard Collared Size 7 from Lot # 536023.
GMT has determined that there has not been complete mix up of the affected lots. However, as a precaution, all non-implanted parts from these lots are being recalled. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers should return affected stock on hand and replacement stock will be provided.
Should this problem not be identified intra-op and the surgery is completed with the use of an incorrectly sized stem (too short / too long), it could lead to loosening, pain or bone fracture and a subsequent revision.
Corin Australia does not recommend that devices already implanted be removed. Please monitor the impacted patient/s per your standard follow-up protocols. |
| Contact Information |
02 9497 7400 - Lin Htet Aung |