| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00296-1 |
| Product Name/Description |
Power-LOAD (Cot Fastener)
Item Numbers: 6390000000, 6390BASIC, 6390SSPA
Units manufactured between Jan 1 2016 to Dec 31 2016
All serial numbers beginning with “16” are within scope of this action
ARTG Number: 275902 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
After installation of the Power-LOAD, the Floor Plate Attachment Brackets (PN: 6390-101-108) which allow the Power-LOAD anchor to be secured to the Power-LOAD floor plate may be found to be broken after removing the anchor.
The manufacturer has advised that broken floor plate attachment brackets will not result in unintended movement of the cot under normal conditions. The holding strength of the cot is reduced as a result of this issue which may result in a detached cot with fastener or a detached fastener component in the event of an emergency service vehicle accident.
To date, there have been no reported injuries as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Stryker is advising that they will be replacing potentially affected parts on all Power-LOAD units manufactured within the suspected time frame. A Stryker Technician will contact users upon receipt of the Notification Response Form provided with the Customer Letter (issued to affected users) to co-ordinate the correction.
This action has been closed out on 06/02/2019 |
| Contact Information |
02 9467 1175 - Customer Service Support |