Device product
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)
Z-2064-2015
Product summary
- Event
- Event 71407
- Status
- Terminated
- Classification
- Class II
- Quantity
- 146 devices
- Official record key
device-enforcement:Z-2064-2015
Official wording
Reason: Product may breach the inner and outer sterile pouches during shipping or handling.
Code information: Lot Numbers: 5679, 5777, 7420, 7588, 7787, 8369, 8605, 8869, 9485, 9688, 18070
Distribution pattern: US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY.
Derived failure modes
-
Unknown
Product may breach the inner and outer sterile pouches during shipping or handling.