| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00451-1 |
| Product Name/Description |
Blackmax, Micromax, Xmax Anspach Pneumatic Drill Systems / Hoses without a pressure relief valve (PRV)
ARTG Number: 141599 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
20/05/2013 |
| Responsible Entity |
|
| Reason/Issue |
The hand piece' s outer hose can rupture without warning if the air flow is blocked during use, this issue involves all drill system hose assemblies manufactured prior to a design change that became effective on May 13, 2009 incorporating a pressure relief valve. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are requested to inspect their stock to determine if they have any pneumatic drill systems without a pressure release valve. All affected device are to be returned to DePuy Synthes for rework/modification. |
| Contact Information |
1800 796 843 - Synthes Customer Service |