| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00882-1 |
| Product Name/Description |
6.5 Cancellous Bone Screw 35mm (Used in total hip joint arthroplasty when the surgeon elects to use a cluster/multi-hole shell in the acetabulum prosthetic component)
Catalogue Number: 2030-6535-1
Lot Numbers: MLH17R, MLJDJT and MLH3K8
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
Stryker Orthopaedics has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are potentially associated with a product label mix. The packaging label associated with a 35mm screw may contain a 25mm screw. |
| Recall Action |
Recall |
| Recall Action Instructions |
Recall and replacement of affected lots |
| Contact Information |
1800 803 601 - Lachlan Mckenzie |