| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01347-1 |
| Product Name/Description |
rHead Radial Head and Uni-Elbow System
Multiple Item Numbers (see attached)
All Lot Numbers
ARTG Numbers:
238712 (Stryker Australia Pty Ltd - Prosthesis, internal, joint, elbow, radial component)
240014 (Stryker Australia Pty Ltd - Coated elbow humerus prosthesis)
240015 (Stryker Australia Pty Ltd - Surgical procedure kit, orthopaedic, reusable) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has conducted a review of the currently available data of the Stryker rHead Radial Head and Uni-Elbow system, and it was found to be inconclusive to continue supporting the performance of the device. The system is intended for replacement of the proximal end of the radius. This includes replacement of the radial head for degenerative or post-traumatic disabilities, presenting pain, crepitation and decreased motion at the radio humeral and/or proximal radio ulnar joint with joint destruction or subluxation visible on x-ray and resistance to conservative treatment.
Post-operatively, the following may occur; implant loosening (septic and aseptic), instability (mod-severe), stress fracture (bone), cyst formation (bone resorption), stiffness, pain, impingement and heterotopic ossification. |
| Recall Action |
Recall |
| Recall Action Instructions |
Stryker is advising customers to inspect inventory for affected product and quarantine it immediately. Stryker will arrange collection of goods from affected sites.
Health care professionals that have patients using the Stryker rHead Radial Head/Uni-Elbow Prosthesis System should continue to follow up those patients in accordance with the routine standard of care and be aware of this issue when doing so.
This action has been closed out on 06/11/2018
This action has been closed out on 06/11/2018 |
| Contact Information |
02 9467 1175 - Stryker |