Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide.
The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.
Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa.
Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa.
The tibial tray lock detail is oversized (larger than specification).
The tibial tray lock detail is oversized (larger than specification).
The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem.
The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem.
An incorrect sizing label was applied to the carton packaging.
The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use
The instrument is incorrectly color coded.
The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.
An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.
Product was labelled with the incorrect manufacturing and distribution dates.
The incorrect product is contained in the packaging.
Incorrect product is contained in the packaging.
The incorrect product is contained in the packaging.
The package contents and package labeling do not match.
The package contents and package labeling do not match.
Lack of sterility assurance
Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.
Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.
One lot of INBONE Tibial Trays is missing the plasma coating.
Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.
Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.
The firm discovered a lack of adequate documentation confirming sterility on certain products.
The firm discovered a lack of adequate documentation confirming sterility on certain products.
The firm discovered a lack of adequate documentation confirming sterility on certain products.
The firm discovered a lack of adequate documentation confirming sterility on certain products.
The firm discovered a lack of adequate documentation confirming sterility on certain products.
The firm discovered a lack of adequate documentation confirming sterility on certain products.
The firm discovered a lack of adequate documentation confirming sterility on certain products.
The firm discovered a lack of adequate documentation confirming sterility on certain products.
The firm discovered a lack of adequate documentation confirming sterility on certain products.
The firm discovered a lack of adequate documentation confirming sterility on certain products.
The firm discovered a lack of adequate documentation confirming sterility on certain products.
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.
Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.
These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction.
These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction.
The term DORSAL was laser etched on the incorrect side on some of the angled handles.
The term DORSAL was laser etched on the incorrect side on some of the angled handles.
The term DORSAL was laser etched on the incorrect side on some of the angled handles.
The term DORSAL was laser etched on the incorrect side on some of the angled handles.
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction.
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction.
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction.
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction.
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Plates manufactured from an incorrect raw material.
Plates manufactured from an incorrect raw material.
Plates manufactured from an incorrect raw material.
Plates manufactured from an incorrect raw material.
Plates manufactured from an incorrect raw material.
Plates manufactured from an incorrect raw material.
Plates manufactured from an incorrect raw material.
Plates manufactured from an incorrect raw material.
Plates manufactured from an incorrect raw material.
There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.