| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00670-1 |
| Product Name/Description |
OASYS Midline Occipital Plate(Intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput –T3))
Catalogue Numbers: 48571044, 48571045, 48571046, 48571047 and 48571048
All lot numbers are affected
ARTG Number: 179439 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
Stryker Spine has received reports from the field indicating post-operative failure of the pin that connects the tulip head to the plate body. The pin can fail when:
- An excess acute load is applied to the pin causing the pin connecting the tulip to the plate to fracture; or
- An excess repetitive load is applied to the pin causing the pin connecting the tulip to the plate to fracture (Fatigue Fracture). |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
The manufacturer, Stryker Spine is currently undertaking an investigation regarding the complaints received. In order to minimise any potential risk to patients while the investigation is ongoing, Stryker Spine recommends routine clinical and radiographic post-operative evaluation for cervical fusion patients implanted with the device. However, should the patient report or exhibit any change in symptoms such as increased pain, weakness, or numbness, more urgent evaluation should be completed. For patients who have had a revision surgery, Stryker Spine recommends routine post-operative care for revised cervical spine fusion patients. For more information, please see http://www.tga.gov.au/safety/alerts-device-oasys-midline-plate-130722.htm . |
| Contact Information |
02 9467 1074 - Stryker Marketing, Neuro and Spine |