| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00538-1 |
| Product Name/Description |
Miami J Select Collar Sets
Miami J Select Collar
Catalogue number: MJS-101
GTIN: 5690967817008
Lot numbers: MX220516 to MX230104
Miami J Select Collar Set
Catalogue number: MJSR-101
GTIN: 5690967817145
Lot numbers: MX220516 to MX230104
ARTG 135078
(Ossur Australia Pty Ltd - Orthosis, spinal, cervical, collar) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that the pressure sensitive adhesive (PSA) hooks attached to the sides of the anterior collar panel can occasionally exhibit poor adhesion. This may lead to them gradually peeling off with repeated doffing, possibly leading to reduced immobilization of the cervical spine. These hooks attach to straps on the posterior panel of the collar. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to examine their inventory and quarantine affected devices. Once the Customer Acknowledgement Form is received a return authorisation will be provided to return the device to Össur.
If any of customers are currently wearing a device, the packaging label should be inspected for the lot number:
· If the lot number is outside of the affected range, no actions need to be taken.
· If the lot number is inside the affected range, healthcare professionals are advised to assess whether a removal and replacement of impacted device currently in use is warranted on a case by-case basis.
· If the packaging label/lot number is not available, healthcare professionals are advised to assess whether a removal and replacement of the impacted device currently in use is warranted on a case-by-case basis. |
| Contact Information |
1300 123 268 - Ossur Customer Service |