| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00206-1 |
| Product Name/Description |
Verso Shoulder Forked Retractor (Comprehensive Instrumentation (2 Prong Retractor))
Part number: 402852
All Lots affected
ARTG Number: 177811 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
An investigation has identified that Verso Shoulder Forked Retractor Part Number 402582 was manufactured using 420 stainless instead of 420 S29 stainless steel. 420 stainless steel is more brittle than 420 S29. The instrument may fracture during use.
If the retractor fractures during surgery, surgical intervention may be necessary to retrieve any fractured pieces. A delay in surgery greater than 30 minutes may occur. If the pieces are unable to be retrieved, the patient would retain a foreign body. |
| Recall Action |
Recall |
| Recall Action Instructions |
The sponsor is advising users to inspect stocks and quarantine the affected units. The sponsor will remove and replace the affected units. This action has been closed-out on 25/01/2017. |
| Contact Information |
02 9483 5426 - Zimmer Biomet |