| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00285-1 |
| Product Name/Description |
Blue Free Strand ORTHOCORD Sutures: Orthocord Blue without needles; Orthocord Blue & Violet without needles; Orthocord Blue & Violet with needles; Orthocord Violet/Blue W/ MO 06 NDLE PK12; Orthocord Violet/Blue W/ OS 06 NDLE PK12 (Sutures used in general soft Tissue approximation and or ligation, including orthopeadic procedures
Product codes: 223111, 223113, 223114, 223115 & 223116
ARTG Numbers: 121837 & 121836 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
28/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
There is an update to the Instructions for Use (IFU) to reflect that Blue Free Strand ORTHOCORD® Sutures are expected to retain 80% of their original strength at six weeks after implantation, instead of 100% as indicated in the current IFU. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Updating the Instructions for Use (IFU) |
| Contact Information |
02 9815 3776 - JJM Quality Assurance |