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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 Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
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;
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