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Type of Product	Medical Device
TGA Recall Reference	RC-2018-RN-00024-1
Product Name/Description	Radiolucent Spine Surgery Frame Material Number: 100731AO Model Number: F-70801 Multiple Serial Numbers ARTG Number: 236335 (Getinge Australia Pty Ltd - Restraint, physical, patient)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	12/01/2018
Responsible Entity	Getinge Australia Pty Ltd
Reason/Issue	Getinge has become aware of a potential risk, which could result in critical harm to the patient if the base of the product were to crack during use. Since the introduction of this product in March 2017, one complaint with no allegation of injury has been reported where the base of the frame cracked as the patient was being prepared for surgery.
Recall Action	Recall for Product Correction
Recall Action Instructions	Getinge Australia is advising customers to immediately remove the Spine Frame from use that are in the serial number range as identified. Getinge Australia representative will contact users to arrange the corrective repair. This action has been closed out on the 16/11/2018.
Contact Information	1800 438 464 - Customer Service Support