The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Linkbio Corp. or your healthcare provider for instructions. Notification method: E-Mail
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LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.. Reason: The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.. Classification: Class II. Quantity: 5 units. Distribution: US Nationwide distribution in the state of Alabama, Florida, and Kansas.
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Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Lack of Assurance of Sterility
Labeling: Missing Label
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.