Recall Z-2540-2018 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
OMNIlife science Inc.
OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cups are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup liners, standard and ApeX-LNK Poly, are intended for use wit
| Date | May 18, 2018 |
| Status | Terminated |
| Reason | The Internal packaging, the pouch and patient labels are improperly labeled. |
| Root cause | Employee error |
| Action | On May 18, 2108, all US Agents holding the affected inventory were notified via telephone. On May 23, 2018, OMNILife Science, Inc. issued URGENT MEDICAL DEVICE NOTICES to their customers advising them that the product is being recalled, should be quarantined and returned for repackaging. For questions call 774-226-1847 or 800-448-6664. |
| Quantity | 16 units |
| Distribution | US Nationwide Distribution - in the states of AZ, CA, CO, IL, FL & MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101976 | INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET Omni Life Science, Inc., Sep 14, 2010 |