Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by these instructions to be processed by the rest of the LIS software.
Class I - Dangerous
Terumo BCT announces a voluntary field action for the Harvest : Adiprep Adipose Transfer System because the affected product is incorrectly labeled and has the potential for operator confusion.
Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
Synthes (USA) Products
Class I - Dangerous
Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.
Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA04712, REF PHA04714 For use with the conserve metal head
MicroPort Orthopedics
Class I - Dangerous
Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.
FMsealer Open Shears. Model FM3001
Domain Surgical
Class I - Dangerous
Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.
Class I - Dangerous
Sterility: Due to a potential incomplete seal on the outer sterile package.
Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. QC measurement results can be affected as well. This issue is only detectable if comparison result of a second measurement is available. The cause for this issue is an error in the software measurement procedure. In children, decreased urea results can point at inborn disorders or urea cycle. Therefore, false normal urea values could lead to delayed/incorrect diagnosis of such a disorder. Besides the patients most at risk, the risk for the overall patient population with falsely low or high values is considered remote. No severe adverse health effects are expected; but, unnecessary diagnostic measures may be initiated. Falsely normal results may result in further necessary examination not being carried out, with the possibility of a delay in the diagnosis and treatment. A medical risk cannot entirely be excluded.
Class I - Dangerous
Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
Oxygen tubing and the oxygen connector of the Hamilton-MR1 could potentially become loose during the preparation for ventilation.
Sterility: Due to a potential incomplete seal on the outer sterile package.
Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
Class I - Dangerous
Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.
Class I - Dangerous
Incorrect Dose when using the reset function.
Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.
A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Case Assembly in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely.
Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.
The application may crash during the cath lab procedure.
Sterility: Due to a potential incomplete seal on the outer sterile package.