Recall Z-2064-2015 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Omnilife Science Inc.
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
| Date | Jul 14, 2015 (initiated Jun 3, 2015) |
| Status | Terminated |
| Reason | Product may breach the inner and outer sterile pouches during shipping or handling. |
| Root cause | Packaging |
| Action | All product is consigned to US Agents until implanted or returned to OMNI. All US Agents holding the potentially affected inventory were notified that the product is being recalled via letter on June 3, 2015. The letter instructs them to immediately discontinue use of the product and contact OMNI Customer Service at 800-448-6664 to request a return materials authorization, and to return the Acknowledgement and Receipt form by FAX to 508-819-3390 or email to cflores@omnils.com. |
| Quantity | 146 devices |
| Distribution | US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090845 | APEX ARC HIP STEM Omni Life Science, Inc., Apr 7, 2010 |