95,025 total recalls in our database
Nuvasive Specialized Orthopedics
During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.
Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
Siemens Medical Solutions USA
Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node block.
There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space.
Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Medline Industries
The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.
Skytron, Div. The KMW Group
VGDF (VGA) Faceplate failure results in failure of video signal for SkyVision Linx 300, a secondary display. Video would continue on the primary source device display
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40mm, however included is a 5mm x 40mm balloon. Use of a balloon that has a smaller diameter than expected could result in inconsequential prolongation of an existing procedure.
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Devicor Medical Products
It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01.
Examination gloves were shipped inadvertently, without to verify barrier integrity.
Ra Medical Systems
Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.