Implants & Prosthetics

Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment

Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay

Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment

Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment

Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment

Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment

Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.

Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.

Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.

Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.

Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.

Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.

54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.

Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.

Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell