| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00002-1 |
| Product Name/Description |
Prosthesis, internal, spine, disc
(The prosthesis is intended as an adjunct to a lumbar discectomy procedure as a means to maintain the relative position of nucleus within the disc space, thereby reducing the risk of a recurrent herniation.)
ARTG Number: 182175 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Intrinsic Therapeutics Inc has identified a manufacturing defect affecting a select number of batches of the delivery tool (instrument). The defect can cause the instrument to break under stress during surgery. This defect does not impact the implant, its performance or possible safety of patients. |
| Recall Action |
Recall |
| Recall Action Instructions |
1. Quarantined all stock on hand in the Global Orthopaedic Technology warehouse;
2. All Stock Recalled and physically had returned to Global Orthopaedic Technology warehouse that was on consignment with 1 hospital and on loan with second hospital.
3. All product recalled, quarantined and returned to the manufacturer.
This action was undertaken prior to consultation with the Therapeutic Goods Administration. |
| Contact Information |
02 8887 0115 - Global Orthopaedic Technology |