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Devices
Device Recall Omnifit Normalized Hip Stem
Model / Serial
6034-0730 OMNIFIT NORMALIZED HIP STEM PJ9MLE
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 Normalized 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 Normalized 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
English
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