| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00860-1 |
| Product Name/Description |
Aequalis Ascend Flex Shoulder System PTC Humeral Stems
Reference Number: DWF602C
Lot Number: AA2028
ARTG Number: 234030 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
Wright Medical has identified a deviation of the manufacturing method for one lot of Aequalis Ascend Flex Shoulder System PTC Humeral Stems. This is a documentary discrepancy with regulatory impacts, but for which the patient risk was assessed as negligible.
The subcontractor (who have manufactured the affected parts), used in fact the manufacturing method validated for Tornier SAS internal manufacturing, whereas the justification for the authorisation to use this method by the subcontractor, was insufficiently documented. |
| Recall Action |
Recall |
| Recall Action Instructions |
Measures to be taken by the customer:
Wright Medical are asking that if any product is with customers, that they:
1. Locate and return parts;
2. Circulate this information to whom it may concern in the hospital; and
3. Inform a Tornier Representative of any adverse event.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
02 8422 2621 - Wright Medical |