Class I - Dangerous
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
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Implants & Prosthetics
ðĨ Medical Devices âĒ 4,589 recalls
Class I - Dangerous
54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.
Class I - Dangerous
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
Abbott Medical
Class I - Dangerous
Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F
Howmedica Osteonics
Class I - Dangerous
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D
Howmedica Osteonics
Class I - Dangerous
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H
Howmedica Osteonics
Class I - Dangerous
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
Howmedica Osteonics
Class I - Dangerous
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E
Howmedica Osteonics
Class I - Dangerous
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
SEASPINE ORTHOPEDICS
Class I - Dangerous
Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64H
Howmedica Osteonics
Class I - Dangerous
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D
Howmedica Osteonics
Class I - Dangerous
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E
Howmedica Osteonics
Class I - Dangerous
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F
Howmedica Osteonics
Class I - Dangerous
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50D
Howmedica Osteonics
Class I - Dangerous
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B
Howmedica Osteonics
Class I - Dangerous
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E
Howmedica Osteonics
Class I - Dangerous
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device, Large, 2.2 IN/PO x 3.5 IN/PO, REF 1501U, Sterile. Product is packaged 1 device per pouch, 25 pouches per primary carton, and 4 primary cartons per shipper box.
3M Company - Health Care Business
Class I - Dangerous
Manufacturing nonconformities are in some lots of the Tube Securement Device, such as the top film layer may be partially or completely missing and some devices may exhibit the appearance of an incorrect shape due to excess material not being removed from the product liner.