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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00112-1
Product Name/Description	Wrench Devices Wrench, Cannulated Socket 10mm Part Number: 910-CW-10L UDI: 0084113214296 Wrench, Combo 10mm Part Number: 915-CW-10 UDI: 0084113214297 Wrench, Swivel 10mm Part Number: 915-FW-10 UDI: 0084113214300 Orthex Wrench 7mm Part Number: C915-CW-07 UDI: 0084113217782 ARTG 302175 (Orthopediatrics AUS Pty Ltd - Surgical procedure kit, orthopaedic, reusable)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	1/03/2024
Responsible Entity	Orthopediatrics AUS Pty Ltd
Reason/Issue	OrthoPediatrics received nine complaints in relation to items without manufacturer logos imprinted. After investigation, OrthoPediatrics has identified these wrenches may corrode after multiple sterilisation cycles. There is a remote possibility of a delay in surgery. Visual inspection of device would determine any corrosion present. No adverse events have been reported to date.
Recall Action	Recall
Recall Action Instructions	The affected product must be returned to Orthopediatrics. Replacement product will be provided for device part numbers 910-CW-10L, 915-CW-10 and C915-CW-07. Part Number 915-FW-10 will no longer be available. Customers are to contact customer service to arrange return of the affected product. No additional corrective actions need to be taken for product already implanted.
Contact Information	jbatts@orthopediatrics.com - OrthoPediatrics