| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00570-1 |
| Product Name/Description |
Cortex Screw Ø 4.5mm, self-tapping, length 20mm, Pure Titanium
Part Number: 414.820
Lot Number: 2610310
ARTG Number: 157068 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
The affected part and lot numbers of the 4.5mm Cortex Screws, length 20mm, may contain a 4.5mm Cortex Screw that is 22mm in length; the screws are both etched and labelled with the affected 20mm part numbers.
The outside package labelling and the etching on the product would indicate to the user that the screw is 2mm shorter than its actual length of 22mm. If detected prior to insertion it may result in a surgical delay while a replacement is obtained or if the surgeon inserts the screw, determines it was the wrong length on radiographic imaging, and then removes and replaces it.
In addition, the potential harm of Damage to Surrounding Structures including damage to articular surface during insertion could occur, depending upon the location and angle of screw. A screw that is too long can also result in Soft Tissue Damage (Soft Tissue Irritation) if not recognised during the procedure. At this time there have been no reports of patient involvement. |
| Recall Action |
Recall |
| Recall Action Instructions |
JJM is advising users to inspect stock and quarantine the affected units prior to their return to JJM. Past surgical results should be reviewed at the discretion of the surgeon for patients who have been implanted with screws from this particular lot number. This action has been closed out on 19/01/2017. |
| Contact Information |
1300 562 711 - JJM Customer Service |