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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00446-1
Product Name/Description	UNIMAX Detachable Endo Pocket Catalogue Numbers: SB936, SB957 and SB979 Lots for SB936: 6252304017, 6252304033, 6252305087 Lots for SB957: 6252207180, 6252303004, 6252303018, 6252304025, 6252304034 Lots for SB979: 6252207182, 6252303007, 6252304026, 6252304035, 6252304047 ARTG 202436 (ConMed Linvatec Australia Pty Ltd - Bag, tissue extraction)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	5/06/2024
Responsible Entity	ConMed Linvatec Australia Pty Ltd
Reason/Issue	ConMed Australia have received reports that the black heat-shrink tubing material supporting the ring at the top of the bag may detach during use. There is a risk it may fall into the surgical site and retrieval could cause a delay in the surgical procedure. ConMed Australia has received no reports of any patient injury or death associated with this problem.
Recall Action	Recall
Recall Action Instructions	-Customers are to check for affected Lots on their inventory, discontinue use of the affected devices immediately and return them to ConMed Australia for replacement. -Complete and return the attached Reply Form to ConMed Australia by fax to 1800 238 298 or email to RegulatoryAU@conmed.com and ConMed will contact affected customers to organise the return and replacement of the products. This action has been closed out on 14/08/2024
Contact Information	1800 238 238 - RegulatoryAU@conmed.com - ConMed Australia Customer