Z-2064-2015 Class II Terminated
FDA device recall Z-2064-2015 was initiated by Omnilife Science Inc. on June 3, 2015 and is designated Class II. Reason for recall: Product may breach the inner and outer sterile pouches during shipping or handling. The recall status is terminated (terminated September 8, 2015). Affected quantity: 146 devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 22, 2015
- Initiation Date
- June 3, 2015
- Termination Date
- September 8, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 146 devices
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)
Reason for Recall
Product may breach the inner and outer sterile pouches during shipping or handling.
Distribution Pattern
US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY.
Code Information
Lot Numbers: 5679, 5777, 7420, 7588, 7787, 8369, 8605, 8869, 9485, 9688, 18070