| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00779-1 |
| Product Name/Description |
Durolane 3ml (synovial fluid supplementation substance)
Product Number: 1081110
Batch Number: 12068-1
ARTG Number: 200304 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has advised that there has been a higher than anticipated number of reports of post-injection knee pain and swelling. In some cases an increase in the intensity of the symptoms have been reported. Pain, swelling and stiffness may limit mobility or use of the limb. Recovery time might be increased and moderate to severe patient discomfort may result. Some patients may have swelling due to varying degrees of effusion and which may require aspiration. Most patients involved with the reported complaints recovered within the listed timeframe in the IFU and known from the clinical studies of the product. Few patients had a protracted recovery time beyond 3 weeks after injection. |
| Recall Action |
Recall |
| Recall Action Instructions |
Please report any issues or adverse reactions to the TGA (refer to "Report a problem with a medical device" http://www.tga.gov.au/safety/problem.htm#device) and to Smith & Nephew Surgical. Customers with affected units are requested to advise Smith & Nephew so that replacement stock can be arranged. |
| Contact Information |
02 9857 3999 - Smith & Nephew Surgical |