Devices

Device Recall Omnifit Eon132

Model / Serial
6098-0630 OMNIFIT EON 132 48HMME, 6098-0630 OMNIFIT EON 132 TAMMME, 6098-0735 OMNIFIT EON 132 0W9MNE, 6098-0940 OMNIFIT EON 132 TN3MLE and 6098-1140 OMNIFIT EON 132 2HNMME
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 Eon || 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 Eon132

Manufacturer

Stryker Howmedica Osteonics Corp.

Manufacturer Address
Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430
Manufacturer Parent Company (2017)
Stryker
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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