Recall Z-2241-2014 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Omnilife Science Inc.
Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA
| Date | Aug 15, 2014 (initiated May 9, 2014) |
| Status | Terminated |
| Reason | Staining on hip implant. |
| Root cause | Manufacturing material removal |
| Action | All product was consigned to US sales Agents until implanted or returned to OMNI. All US Agents holding the inventory were notified on May9, 2014 by phone and follow up email that the product is being recalled. Customers have been instructed to immediately discontinue use and return the product to OMNIlife science. |
| Quantity | 13 devices |
| Distribution | US: CA, OK, VA, FL, MA, NY, TX |
| 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 |