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Devices
Device Recall OMNIFIT HA HIP STEM
Model / Serial
x6017-0525A OMNIFIT HA HIP STEM #5 3PMMNE and 6017-1035A OMNIFIT HA HIP STEM #10 NKAMME
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
Product Description
Omnifit HA 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
Recall of Device Recall OMNIFIT HA HIP STEM
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Manufacturer
Stryker Howmedica Osteonics Corp.
Manufacturer Address
Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430
Manufacturer Parent Company (2017)
Stryker
Source
USFDA
Language
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