Recall Z-0237-2022 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
OmniLife Science
OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.
| Date | Oct 1, 2021 |
| Status | Terminated |
| Reason | The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing. |
| Root cause | Process control |
| Action | Affected agents and representatives were notified by email, with initial communication sent via a quarantine form on 10/1/21. Additional notices titled "Urgent Medical Device Recall" were emailed out on October 15, 2021. Customers were instructed to immediately quarantine lot 38933 and return the product to OMNI. Customers were provided with a response form and asked to complete and return the form to the recalling company by FAX to 508-819-3390 or my email at christina.rovaldi@coringroup.com. For further information contact Christina Rovaldi, RA/QA Manager at 774-226-1847 or 800-448-6664. |
| Quantity | 7 |
| Distribution | US Distribution to states of: Colorado and Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041950 | APEX K2 HIP SYSTEM Apex Surgical, LLC, Dec 21, 2004 |