Stryker Instruments Div. of Stryker Recalls

Hazard: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Hazard: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Hazard: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Hazard: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Hazard: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Hazard: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Hazard: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Hazard: Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial numbers Thoracic Pedicle Feelers that are used in conjunction with the Stryker¿ Navigation System because the settings on the machine were higher than intended. This change led to increased energy directed onto the tip of the Thoracic Pedicle Feeler which caused material degradation where the laser marks exist. There is the potential for the tip of the Thoracic Pedicle Feeler to break.

Hazard: Product shipped proximate to or past the expiration date listed on the product label.

Hazard: Stryker Instruments issued a notice of correction for an update to cleaning practices for the Stryker SmartLife Large Aseptic Housings following complaints of deterioration to the housing and the top and bottom housing separating at the weld. Using cleaning practices outside of the HIFU could lead to housing separating at the weld.

Hazard: Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.

Hazard: Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.

Hazard: Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.

Hazard: Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.

Hazard: Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.

Hazard: Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.

Hazard: Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.

Hazard: Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen¿ Generator, because the instructions for use incorrectly contained instructions supporting the sterilization of the MultiGen¿ cables.

Hazard: Stryker Instruments is voluntarily recalling the Sagittal Blade 18.0X.97X90MM due to the potential for a sterile barrier breach in the product's packaging.

Hazard: Stryker initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potential for the device to experience system errors causing the device to shutdown if high levels of electromagnetic interference are present in the operating room.

Hazard: The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Valve resulting in a cement backflow towards the injector handle. Potential for delay in surgery if additional cement needs to be prepared for the injection procedure.

Hazard: A variation in flute depth on the routers was observed. The variation in flute depth may cause the routers to be more susceptible to breakages. Risk to Health: Injury to critical soft tissue requiring surgical intervention may occur.

Hazard: Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reaction (inflammation) necessitating surgical intervention.

Hazard: Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reaction (inflammation) necessitating surgical intervention.

Hazard: Due to the buildup of grease within the hose and motor, the product may require multiple attempts to start. The grease may also migrate into the attachment end of the motor. There is a negligible possibility that the orange grease may leak from the attachment end of the motor and contaminate the surgical wound resulting in soft tissue inflammation.

Hazard: The affected scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, the affected SurgiCounter scanner may display an error message (code=2). Also, the SurgiCounter scanner software version number is not appropriately displayed in the SC360 application during installation.

Hazard: The Spetzler Claw Tip was packaged with the incorrect Tip Sleeve Assembly. The Tip Sleeve Assembly included in the packaging is the incorrect size. Risk to Health: If the Tip Sleeve Assembly does not fit the Spetzler Claw" Tip, a surgical delay may occur while an alternate Tip Sleeve Assembly is retrieved.

Hazard: During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.

Hazard: During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.

Hazard: During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.