Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. To reduce incidence of sub-optimal fit between provisional femoral heads and the mat
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
HORIBA Medical Irvine Technical Support received reports from some customers that have experienced high recover values for Hemoglobin when using Minotrol 16 lot #MX090 (Level High). Customer communication was sent 10/01/2010.
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Class I - Dangerous
The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature
Vital Signs Colorado
Class I - Dangerous
There is a potential for epistaxis during use of the Disposable General Purpose 9 French Temperature Probe.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Class I - Dangerous
The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Class I - Dangerous
The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) if the product had subjected to an EtO
The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. To reduce incidence of sub-optimal fit between provisional femoral heads and the mat