| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00427-1 |
| Product Name/Description |
BioMend Absorbable Collagen Membrane/Wound Dressing
BioMend Absorbable Collagen Membrane;
BioMend Extend Absorbable Collagen Membrane;
CollaCote Absorbable Collagen Wound Dressing for Dental Surgery;
CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery; CollaTape Absorbable Collagen Wound Dressing for Dental Surgery
Multiple lot and catalogue numbers affected
ARTG Number: 159199 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
Due to a manufacturing process deviation these products may have been released with higher levels of endotoxins than permitted by the specifications for the products. |
| Recall Action |
Recall |
| Recall Action Instructions |
Zimmer Dental is requesting their customers to remove any affected units from service. Patients implanted with affected products should be monitored for fever in the immediate postoperative period according to the standard hospital protocol. |
| Contact Information |
1800 241 916 - Zimmer Customer Service |