Class I - Dangerous
Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
Stryker Howmedica Osteonics
Class I - Dangerous
The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instructions For Use (IFU) states the device are sterilized via gamma irradiation and should not be resterilized. Since the IFU states the devices are sterile, no instructions for moist heat sterilization are provided.
Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs) that control the sub-systems. The problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. Replacement PCBs are now available to correct the issues. Only the Model C20 is affected in the US.
Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics
Class I - Dangerous
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics
Class I - Dangerous
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics
Class I - Dangerous
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis
Fresenius Medical Care Renal Therapies Group
Class I - Dangerous
On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L.
Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics
Class I - Dangerous
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
The recliners were shipped without the foot rest ottoman linkage side shields, which could result in consumer injury.
The item was recalled due to an increased user/patient risk of exposure to fire and/or electrical shock due to the failure of the PRN 50-M+ Digital Writer
Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics
Class I - Dangerous
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Stryker Howmedica Osteonics
Class I - Dangerous
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)
Nihon Kohden America
Class I - Dangerous
The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boards which were intended to provide protection from electrostatic discharge failed to prohibit unintentional current flow.
When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated Monitor Units (MU). Potential for unintended radiation exposure.
MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
Viewray Incorporated
Class I - Dangerous
The system loaded a completion fraction in the incorrect order after a treatment interruption.
Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.
Philips Electronics North America
Class I - Dangerous
If arm is not fastened securely it could fall down.
MEVION S250 Radiation therapy system
Mevion Medical Systems
Class I - Dangerous
The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment.
Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.
Bard Peripheral Vascular
Class I - Dangerous
Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
Class I - Dangerous
There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention.
INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
Toshiba American Medical Systems
Class I - Dangerous
When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value to the software. Consequently, the software defined the data as an "abnormal value" and it stopped displaying dose data and the dose data was lost. The following message was displayed, "Dose meter abnormal, Dose info disabled".