Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
Implants & Prosthetics
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Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Medtronic Vascular
During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.
Medtronic Neuromodulation
The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed.
The processing of collected episode data may fail due to a software error.
Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.
Medtronic Neuromodulation
The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed.
Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
There is a potential for distal tip dislodgement or separation.
There is a potential for distal tip dislodgement or separation.
There is a potential for distal tip dislodgement or separation.
The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.
There is a potential for distal tip dislodgement or separation.
There is a potential for distal tip dislodgement or separation.
There is a potential for distal tip dislodgement or separation.
Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004.
Laboratoires Bodycad
There is a risk of breakage of the torque limiting adaptor if used counterclockwise and it must not be used with a power tool due to no test data validating this use.
GM Helix Acqua Implant 3.5x10, Article No. 140.944
Jjgc Industria E Comercio De Materials Dentarios Sa
3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.
ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
Implant Direct Sybron Manufacturing
Packaged dental implant contains a different size then the size declared on the labeling.
ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
Implant Direct Sybron Manufacturing
Packaged dental implant contains a different size then the size declared on the labeling.
Potential for breakage of the ECG electrode carbon stud from the eyelet.
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure