| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01385-1 |
| Product Name/Description |
Acetabular Cup Introducer (32mm)
Product Number: 962636000
Lot Number: 0SA203015
ARTG Number: 132270 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Johnson & Johnson Medical (JJM) has identified an issue with the Acetabular Cup Introducer (32mm) where the nylon ejector slug may melt during the autoclave process. This may cause the ejector to be inoperable and the cup introducer to be difficult to remove after cup placement. |
| Recall Action |
Recall |
| Recall Action Instructions |
JJM is requesting Customers:
1. Immediately inspect the device(s) in your possession to determine if your facility has affected product. If you do please quarantine this product prior to returning it to JJM;
2. Return a copy of the supplied acknowledgement form, even if you do not have any affected product, by fax to 1800 241 101 or email to ra-jnjau-recallsanz@its.jnj.com;
3. Return any affected product as soon as possible, but within 30 business days, by contacting JJM Customer Service on 1300 562 711;
4. Forward the recall notice to anyone in your facility who needs to be informed; and
5. If any potentially affected product(s) has been forwarded to another facility, contact that facility to arrange inspection and return (if applicable).
This action has been closed out on 16/08/2018 |
| Contact Information |
1300 562 711 - Johnson & Johnson Medical Customer Service |