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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00021-1
Product Name/Description Comprehensive Reverse Shoulder Tray

Item Number: 115340

Lot Numbers: 132030, 172670, 310620, 367330, 482000, 558910, 648860, 950390

ARTG Number: 263033
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 17/01/2017
Responsible Entity Zimmer Biomet Pty Ltd
Reason/Issue A higher than anticipated fracture rate has been identified for certain lots of the Comprehensive Reverse Shoulder Trays manufactured prior to September 2011. Devices manufactured after this date have design enhancements that increased the strength of the device.
Recall Action Hazard Alert
Recall Action Instructions Zimmer Biomet is advising surgeons to monitor patients through regular consultations to determine the need for any treatment. This action has been closed-out on 07/09/2018.
Contact Information 02 9483 5426 - Zimmer Biomet