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The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.
Potential for attenuation degradation over time, decreasing the lifespan.
Potential for attenuation degradation over time, decreasing the lifespan.
Potential for attenuation degradation over time, decreasing the lifespan.
Potential for attenuation degradation over time, decreasing the lifespan.
Potential for attenuation degradation over time, decreasing the lifespan.
Potential for attenuation degradation over time, decreasing the lifespan.
Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
Augmentation devices failed bacterial endotoxin testing.