Devices

Device Recall OMNIFLEX MHA HIP STEM SERIES

Model / Serial
Product number: 6046-0425, Lot 24897301 and Product number: 6046-0830, Lot 24352201.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution.
Product Description
Omniflex-HA Hip Stem W/C Taper. || Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
Manufacturer
Stryker Howmedica Osteonics Corp.
1 Event
- Recall of Device Recall OMNIFLEX MHA HIP STEM SERIES

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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