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Type of Product	Medical Device
TGA Recall Reference	RC-2022-RN-01549-1
Product Name/Description	BIOSTOP G Bioresorbable Cement Restrictor Models numbers: 546308000, 546310000, 546312000, 546314000, 546316000, 546318000 & 546320000 Sizes: 8, 10, 12, 14, 16, 18 & 20 All lots ARTG 126998 (Johnson & Johnson Medical Pty Ltd T/A Depuy Australia - BIO Stop G Centraliser - Cement, orthopaedic, bone plug)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	15/12/2022
Responsible Entity	Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Reason/Issue	Johnson & Johnson Medical (JJM) is recalling all lots of BIOSTOP G Bioresorbable Cement Restrictor as a precautionary measure because recent in vitro testing of endotoxin levels from a sample restrictor fully dissolved in solution were calculated at >20,000 endotoxin units (EU)/device over 24 hours, based on restrictor size. This exceeds the recommended value of 20 EU/device as referenced in the current Medical Device Standards Order (Endotoxin Requirements for Medical Devices) 2018. To date, there has been no evidence of a signal in any post market surveillance data reviews, including complaints related specifically to endotoxins.
Recall Action	Recall
Recall Action Instructions	JJM is advising customers to quarantine impacted product on site and contact JJM for an immediate return and replacement. JJM is advising healthcare providers who have used BIOSTOP G on patients to continue to follow those patients pursuant to their standard of care for those procedures. This action has been closed out on 29/02/2024
Contact Information	1800 252 194 - JJM Customer Service