| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01296-1 |
| Product Name/Description |
AutoTac Delivery Handle 400-200 and AutoTac Titanium Tack Starter Kit 400-270 (Dental membrane fixation kit)
Multiple lot numbers
ARTG number: 132758 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
BioHorizons has found that the cleaning instructions may not be sufficient to remove residual contaminants after surgical use. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Affected lot numbers are identified in the customer letters sent by BioHorizons Australia. Re-clean the handle and sterilise prior to each use or subsequent re-use following the updated instructions provided with the customer letter. Early version of the AutoTac Handle that cannot be disassembled, cleaned and reassembled following the updated instructions are to be returned to BioHorizons Australia for replacement. |
| Contact Information |
02 9317 2088 - BioHorizons Australia |