Medical device recalls

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

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

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

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

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

Software defect which may potentially result in one or more images missing in a study

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

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.

During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.

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.

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.

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.

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.

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.

Firm has received 6 complaints that the Heat Moisture Exchanger (HME) disconnected from the closed respiratory circuit during use. If the HME separates, the ventilator circuit may not provide adequate ventilation to the patient, potentially resulting in lack of oxygen leading to hypoxia or death.

There have been reports of the suction catheter coming apart from the device assembly during use.

The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm.

Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.

The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.

No results/incorrect results due to failure of the hybridization heater.

Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.

Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile observed

Examination gloves were shipped inadvertently, without to verify barrier integrity.

Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury.

Labeling discrepancy for the Rated Burst Pressure (RBP) value.

Product was shipped with refrigeration (ice) instead of frozen (dry ice).