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Device Recall OmniFit Eon
Model / Serial
Catalog Number/Lot Code: LSP48.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution.
Product Description
OmniFit Eon 127 degree and 132 degree Surgical Protocol; || Stryker. || Surgical protocols instruct surgeons on proper surgical technique.
Manufacturer
Stryker Howmedica Osteonics Corp.
1 Event
Recall of Device Recall OmniFit Eon
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Manufacturer
Stryker Howmedica Osteonics Corp.
Manufacturer Address
Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
Manufacturer Parent Company (2017)
Stryker
Source
USFDA
2 devices with a similar name
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Device Recall Omnifit EON Surgical Protocol
Model / Serial
Literatur Number LSP48 4/04
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution --- including USA and countries of Canada, Australia, Latin America and Greece.
Product Description
Omnifit EON Surgical Protocol; || Literature Number: LSP48 4/04 || Stryker Howmedica Osteonics Corp., Mahwah, NJ
Manufacturer
Stryker Howmedica Osteonics Corp.
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.
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