ðĨ Medical Devices âĒ 4,589 recalls
Paltop Advanced Dental Solutions
Surface micro/nano topography on some of the implants contained within this lot may not be consistently present over the entire surface of the implant.
The metal cannula are potentially too loose and may become loose when applying the filing material.
Quality Electrodynamics
Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
Implant Direct Sybron Manufacturing
The incorrect device was packaged in the vial.
Quality Electrodynamics
Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
Quality Electrodynamics
Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
Quality Electrodynamics
Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.
Quality Electrodynamics
Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.
Quality Electrodynamics
Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens Extremity Coils.
Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component
Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft product with the diameter size of 16 x 9 mm is likely incorrectly packed inside of the carton which was labeled to contain a HEMASHIELD PLATINUM Woven Double Velour Vascular Graft product with the diameter size of 16 x 8 mm ((REF: M00202166168P0, Lot: 18K31, SN: 1190443415, size 16 x 8 mm).
Boston Scientific
Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.
Boston Scientific
Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.