The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
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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.
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
Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Recall was initiated due to the incorrect labeling on package.
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge.
Stryker Orthobiologics
Class I - Dangerous
When preparing plasma using VitaPrep, it was reported that a small amount of blood collected in the bottom of the centrifuge cup following the centrifugation step. Firm has since discovered that if blood is present in the Luer connection of the VitaPrep following the blood draw step, this blood could be displaced to the outside of the syringe when the VitaPrep cap is reattached to the syringe. T
Class I - Dangerous
The tulip portion of the screw assembly can disengage from the shank after implantation.
Zimmer Inc. is initiating a removal of the Multipolar¿ Bipolar Cup Liner 22 mm J.D. (item 00-5001-040-22) due to reports that the split poly ring was incorrectly assembled.
INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
Carl Zeiss Meditec
Class I - Dangerous
A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
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
Class I - Dangerous
Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Recall was initiated due to the incorrect labeling on package.
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
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 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.
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.