BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
Biomet
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
A security-only update was released via remote diagnostics on January 14, 2020 to customers with Windows 7 operation system. Shortly after the releases some customers reported that Data Management System computers would not restart. If the computer is unable to restart, then the system cannot download data generated from MicroScan instruments or manually entered microbiology test results, resulting in a potential of delayed results.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13
Siemens Medical Solutions USA
Class I - Dangerous
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
Biomet
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
Biomet
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class I - Dangerous
The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device
Class I - Dangerous
Sterility compromised due to packaging pouches that may not be sealed properly
BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
Biomet
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00
AAP Implantate Ag
Class I - Dangerous
The company has become aware that the soft tissue retractor is not always removed during the sawing process. This can result in damage to the soft tissue retractor in which abrasion debris can develop and remain in vivo.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class I - Dangerous
The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device
Class I - Dangerous
Due to customer reports it has been determined that the inoculation system contains the incorrect prompt wands. Use of the incorrect wands could result in false -susceptible results, false-resistant results, possible misidentifications, or possible out-of-range Quality Control results.
Class I - Dangerous
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Class I - Dangerous
Complaints of sparking of the tips of the electrosurgical device used in RF surgical procedures. The use of the affected treatment tips could contribute to potential skin burns.