| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01468-1 |
| Product Name/Description |
Offset Cup Reamer Handle
(used to hold both the Registration Array during Registration and the Acetabular Reamer Basket during acetabular reaming in total hip procedures)
Item Number: 207080
All Lot Numbers affected
Contained within trays: 151550, 151550-T
ARTG Number: 223107 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has received reports of two potential issues related to the Offset Cup Reamer Handle. The weld on the U-joint of the Handle may become damaged over time, potentially causing the pin or pieces of the pin to fall into the wound. If that occurs, and the surgery proceeds with reaming, the pin or pieces of the pin may fall into the wound, which may be removed if visible or may be left in the wound. The handle also may not fully engage with the registration array and/or Reamer Basket. If that occurs, the surgery may proceed using a backup offset reamer handle, a straight reamer handle or manual instrumentation. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to inspect their inventory for affected product and quarantine it immediately. A Stryker representative will coordinate the return of any affected products. This action has been closed-out on 28/06/2017. |
| Contact Information |
02 9467 1175 - Stryker Recalls Specialist |