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Crédits
Devices
Device Recall Onmifit HFX Hip Stem
Modèle / numéro de série
6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132 P7MMME, 6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132 RHWMME, 6070-0730A OMNIFIT HFX HIP STEM SIZE #07 132 VJMMME, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132 0J0MNE, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132 D9VMME, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132 T9RMME, 6070-0830A OMNIFIT HFX HIP STEM SIZE #08 132 VK0MME, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 0HDMNE, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 0HEMNE, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 P7XMME, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 RE8MME, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 REDMME, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 VK2MME, 6070-0935A OMNIFIT HFX HIP STEM SIZE #09 132 VK3MME and 6070-1140A OMNIFIT HFX HIP STEM SIZE #11 132 0HKMNE
Classification du dispositif
Orthopedic Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
Description du dispositif
Omnifit HFX Hip Stem || These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.
Manufacturer
Stryker Howmedica Osteonics Corp.
1 Event
Rappel de Device Recall Onmifit HFX Hip Stem
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Fabricant
Stryker Howmedica Osteonics Corp.
Adresse du fabricant
Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430
Société-mère du fabricant (2017)
Stryker
Source
USFDA
Language
English
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