Lack of Assurance of Sterility: Sterility of product is not assured.
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Lack of Assurance of Sterility: Sterility of product is not assured.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lack of Assurance of Sterility: Sterility of product is not assured.
The SFD/IDD safety mechanism may not engage properly at the lower range of SFD/IDD travel. This mechanism is installed to hold and prevent the SFD/IDD from falling due to a counterweight cable failure. The lower range of travel is 1.1 in (28mm) from the lowest point of normal SFD/IDD vertical compression. A fall of the SFD/IDD could result in an injury to a patient or operator.
The software was failing to determine new patient locations if imaging is not enabled during treatment.
Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used various failures may occur which may ultimately lead to revision surgery or a delay in surgery.