When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this error.
Stryker Instruments Div. of Stryker
161 recalls • • Categories: Surgical Instruments, Other Medical Devices, Diagnostic Equipment, Implants & Prosthetics, Infusion Pumps
Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels may result in lower than expected results.
Class I - Dangerous
Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard.
Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.
Due to a distribution error, product from the affected lot was shipped expired.
Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
Class I - Dangerous
Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
Class I - Dangerous
Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may result in use errors potentially causing or contributing to nerve injury.
Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may result in use errors potentially causing or contributing to nerve injury.
During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Class I - Dangerous
Separation of material layers may occur, causing a potential risk of exposure to contaminants.
Class I - Dangerous
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Class I - Dangerous
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Class I - Dangerous
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Class I - Dangerous
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Class I - Dangerous
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Class I - Dangerous
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Class I - Dangerous
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Class I - Dangerous
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
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.
Class I - Dangerous
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Class I - Dangerous
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Product shipped proximate to or past the expiration date listed on the product label.
Class I - Dangerous
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.
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
Class I - Dangerous
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.
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.
Class I - Dangerous
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.
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.
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.
Class I - Dangerous
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.
Class I - Dangerous
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.
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.
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.
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.
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
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.
The Guidewire Introducer Needle (0910-192-000) was shipped after the documented expiration date or with minimal time until expiration. There is a potential risk of a soft tissue infection to the patient if device is used after expiration date.
The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be out of specification. This can cut or dislodge the PTFE seal and cause a leak between the Rover and Docker couplers during docking or leaking from the Rover coupler after docking. The potential hazard is waste fluid and/or fresh water dispensed from the Neptune 2 Rover at the incorrect time.
Stryker Instruments is recalling the Stryker SelectCore Variable Throw Biopsy Device due to the potential for for the stylet to eject from the SelectCore device during actuation.
Stryker Instruments is initiating a recall of the Neptune 2 Waste Management System due to complaints related to installation failures of the Neptune 2 diverter valve assembly during docking.
Potential sterility breach in the packaging.
Stryker initiated a device recall of the Navigation System II-Cart, Camera Articulated Arm because there is a potential that the weld seam between the main stud and the two flaps on the Articulated Arm was not welded in the correct location, which may result in a potential failure of the arm joint.
Class I - Dangerous
Potential for the device cannula to overthrow past the intended length.
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as designed. The firm is initiating a software correction to address the issue.
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
Stryker is recalling System 6 Aseptic Housing, due to a failed Continuous Bond Line Test from a housing without a continual weld. Customers are instructed to return recalled product to Stryker.
A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled with an incorrect expiration date of 2412-12-01. The correct expiration date should have read 2014-12-01.
Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.
The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding.
The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding.
Class I - Dangerous
The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive heat at the tip.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.