The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
Class I - Dangerous
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17)
Howmedica Osteonics
Class I - Dangerous
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17)
Howmedica Osteonics
Class I - Dangerous
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
Prismaflex Control Unit
Baxter Healthcare
Class I - Dangerous
Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17)
Howmedica Osteonics
Class I - Dangerous
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
Class I - Dangerous
May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stain
BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277
Becton Dickinson & Company
Class I - Dangerous
The kits contain surgical gowns which were subject to a recall by the supplier.
Class I - Dangerous
A software issue that may affect the analyzer's result accuracy.
BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000435
Becton Dickinson & Company
Class I - Dangerous
The kits contain surgical gowns which were subject to a recall by the supplier.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17)
Howmedica Osteonics
Class I - Dangerous
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
Class I - Dangerous
There is a remote potential for the sterile packaging of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient, there may be a remote risk of infection.
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile, Catalog # 504-02-62E-R, UDI (01)07613327012439(17)
Howmedica Osteonics
Class I - Dangerous
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
Applied Medical Resources
Class I - Dangerous
Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(17)
Howmedica Osteonics
Class I - Dangerous
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.