| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00794-1 |
| Product Name/Description |
Surgical Instruments with flexible shafts
Description & Article
RM Classic
Countersink reamer flex Gen.1- 3.14.251
Reaming shaft flex. Gen.1- 3.15.252
Countersink reamer flex. Gen.2- 3.14.256
Reaming shaft flex. 46-52 Gen.2- 3.14.257
Reaming shaft flex. 54-64 Gen.2- 3.14.258
Reaming shaft flex. 60-68 Gen.2- 3.14.259
Shaft flex. Gen.1- 3.40.501
Countersink reamer flex. Gen.3- 55.02.1901
Reaming shaft flex. Gen.3- 55.02.1903
seleXys Shaft flex- 5502.00.2
Shaft flex- 3.14.545 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
The validated process for the flexible shaft provides directions for a combined manual and mechanical cleaning/disinfection procedure. If the mandatory manual process as described in the processing instruction cannot be ensured/ performed, instruments by Mathys Ltd with flexible shafts may not be used. Mathys Ltd received feedback from hospitals that although the Guidelines for processing and sterilising instruments were followed, residues on the instrument were still found. Therefore Mathys has developed an update to the processing instructions for the concerned instruments. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Mathys is notifying end users of the validated method for cleaning/disinfection of flexible shafts. |
| Contact Information |
+61 418 889 974 |