| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00419-1 |
| Product Name/Description |
Apex 10mm reamer
ARTG Number: 183711
CER-227: 16-May-2011- 8.5mm REAMER Lot L0805
CER-257: 10-Aug-2011 - 16mm REAMER Lot L0805
CER-358: 18-0ct -2012 - 10mm REAMER Lot L0805 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
Sequential reaming of the patient's femur was being carried out during a Total Hip Replacement(THR) procedure. Following the use of the 8mm reamer, the 10mm reamer was introduced. During reaming the bottom of the reamer broke off while lodged in the patients femur, approximately 40mm below the resection level. A distal window was cut into the femur, and the broken section of the reamer removed. Under torque the reamer broke at a weld joint. The joint was insufficiently strong.
This action is undertaken prior to notifying the TGA. |
| Recall Action |
Recall |
| Recall Action Instructions |
Global Orthopaedics Technology has retrieved, quarantined and returnign all affected reamers to the manufacturer. The manufacturer, Omni Life Sciences, has obsoleted the design used for the affected reamers. |
| Contact Information |
02 8887 0164 - Global Orthopaedic Technology |