| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01033-1 |
| Product Name/Description |
ADM/MDM Ball Impactor Tip and ADM Rim Impactor Tip (reusable surgical instrument used to implant Stryker's Automatic Dual Mobility (ADM) and/or the Modular Dual Mobility (MDM) Acetabular Systems)
ADM/MDM Ball Impactor Tip
Catalogue Numbers: 12350013 (12350303A-T, 12350306-T, 12350306V-T, 12350306C-T)
ADM Rim Impactor Tip
Catalogue Numbers: 12350014 (12350303A-T)
All Lot Numbers Affected
ARTG Number: 181721 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has received complaints associated with cracks and/or fractures of the Ball Impactor Tip and Rim Impactor Tip instruments. The potential hazards include;
- Cracked or fractured Ball impactor Tip/Rim Impactor Tip
- Loose fragments form the Ball impactor Tip/Rim Impactor Tip
- Insufficient locking strength of the MDM liner (Ball Impactor Tip only). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Stryker is releasing updated surgical procedures and also updating the loan dockets, recommending the use of a slotted mallet to be used to impact the impactor handle, and emphasising that all tips should be inspected for deformation and cracks before use. |
| Contact Information |
02 9467 1111 - Stryker Orthopaedics |