The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
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.
Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking
Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
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
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant.
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
SURGIFLO Hemostatic Matrix Kit & SURGIFLO Hemostatic Matrix Kit with Thrombin have an issue within the packing process where a cut could potentially breach the double Tyvek pouch of the packaging.
The firm recalled the Freedom Cordless LED Headlight because some units were assembled with an incorrect component in the control board electronics that may cause some Freedom Cordless LED Headlight units to become warm to the touch; however, no skin damage will occur.
When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of moving the Implant Guides, and possibly the implant, too far into the disc space creating the potential for injury to the patient. The instructions for Use for the S-Lift Implant Guides will be amended to add the following warning: "Care is to be taken to not over insert the Implant Guides
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
Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively.
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 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.
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.