Devices

Device Recall Apex ARC Hip Stem

Model / Serial
Lot Numbers: 5679, 5777, 7420, 7588, 7787, 8369, 8605, 8869, 9485, 9688, 18070
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY.
Product Description
Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA || Product Usage: || The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)
Manufacturer
Omnilife Science Inc.
1 Event
- Recall of Device Recall Apex ARC Hip Stem

Manufacturer

Omnilife Science Inc.

Manufacturer Address
Omnilife Science Inc., 50 Oconnell Way Ste 10, East Taunton MA 02718-1394
Manufacturer Parent Company (2017)
Omnilife Science Inc
Source
USFDA

One device with a similar name

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Device Recall Apex Arc Hip Stem, Size 2, HA Coated

Model / Serial
Lot: 17284
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US: CA, OK, VA, FL, MA, NY, TX
Product Description
Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
Manufacturer
Omnilife Science Inc.

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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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