| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00735-1 |
| Product Name/Description |
Tritanium PL 6mm
Item Numbers:48950066 & 48954066
Lot Numbers: A8AM, A8T2
ARTG Number: 265560
(Stryker Australia Pty Ltd - Spinal cage) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
22/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
Stryker Australia has discovered that two (2) lots of Tritanium-PL Cages, part number 48950066 (lot # A8AM) and part number 48954066 (lot # A8T2), were shipped and sold to Australia without Market Release Approval. The Tritanium-PL Cage product family has been registered and approved in Australia. However, the specific part numbers 48950066 and 48954066 were not registered in Australia. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker Australia is requesting recipients of the letter to confirm whether they possess any affected stock and to inform any parties who may have received affected stock and to inform Stryker of this using the supplied response forms.
A hazard alert is also being issued.
This action has been closed out on 04/02/2019 |
| Contact Information |
02 9467 1175 - Stryker |