| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00859-1 |
| Product Name/Description |
OtisMed ShapeMatch Cutting Guides (used to assist in the positioning of knee arthroplasty components and in guiding the marking of bone before cutting)
Catalogue Number: TR3100-L & TR3100-R
ARTG Number: 179665 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
In April 2013, Stryker Orthopaedics issued a Safety Alert (TGA Ref.: RC-2013-RN-00323-1) to users to request that a hold be placed on further procedures using OtisMed ShapeMatch Cutting Guides to investigate the Product Experience Reports received from customers. Stryker Orthopaedics stated that further information would be provided on completion of the investigation.
The investigation identified that the surgical protocol for the ShapeMatch Cutting Guides did not provide sufficient information on the position of the cutting guide, the need for osteophyte/soft tissue removal, the requirement for proper axial drilling, and the need to avoid angulation and mal-alignment. The approved pre-operative plan did not provide sufficient information regarding the need for osteophyte removal. The values displayed via the OtisMed.net web portal were inconsistent with the pre-operative planning values used to manufacture some of the ShapeMatch Cutting Guides. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
The pre-operative plan and surgical protocol has been revised to include the information identified during the investigation e.g., addition of warnings, inclusion of additional text including new images to better illustrate the issues. Surgeons are advised that no additional patient follow-up or monitoring is required apart from usual routine follow-up, which will identify any issue. Stryker is advising that symptomatic patients will present to their Health Care Practitioner. If any potential hazard or harms are detected by the Health Care Practitioner the appropriate action shall be taken. For more details, please see http://www.tga.gov.au/safety/alerts-device-otismed-shapematch-130826.htm . |
| Contact Information |
1800 803 601 - Stryker Orthopaedics |