| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00123-1 |
| Product Name/Description |
T-Adaptation Plate 1.3, head 3 holes, shaft 8 holes, Stainless Steel, and T-Adaptation Plate 1.3, head 4 holes, shaft 8 holes, Stainless Steel (orthopaedic fixation plates)
Part Numbers: 221.333 and 221.334
Lot Numbers: 3488161 and 3488162
ARTG Number: 157069 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
5/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
The listed lot numbers of the T-Adaptation Plate 1.3, 4 holes (221.334) and the T-Adaptation Plate 1.3, head 3 holes (221.333) were mis-packaged. Part number 221.334 was labelled as a 3 hole plate (221.333) instead of a 4 hole plate, whereas part number 221.333 was labelled as a 4 hole plate (221.334) instead of a 3 hole plate. |
| Recall Action |
Recall |
| Recall Action Instructions |
Synthes is requesting users inspect and return any affected stock to Synthes for replacement |
| Contact Information |
1800 796 8435 - Synthes Customer Service |