| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00531-1 |
| Product Name/Description |
Safety Clip - Hoffmann Limb Reconstruction Frame (LRF) Bone Transport
Item Number: 49330401
Lot Numbers: J49236, V07241, V30655, V47575, V49404
ARTG Number: 258035 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has found that there is the potential for loosening of the safety clips from the intended position on the Quick Release Mechanism of the Transport Struts. In the case of no safety clip and/or overloading, the frame may loosen, bend or break in time, causing frame stability collapse. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is advising customers to immediately inspect inventory and quarantine affected product. Stryker will coordinate return of the product and provide credit. Clinicians are advised to inspect if the Safety Clips are still in place when patients come in for routine follow up examination and replace the Safety Clips, and to consider contacting patients that do not show up for routine follow up examination. The need to replace the entire Hoffmann LRF Bone Transport if indicated should also be considered.
This action has been closed-out on 21/03/2018. |
| Contact Information |
02 9467 1175 - Stryker |