Recall Z-2445-2015 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Omnilife Science Inc.
APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.
| Date | Aug 21, 2015 (initiated Jun 4, 2015) |
| Status | Terminated |
| Reason | The device may have improper screw hole placement due to inaccurate location of the index line. |
| Root cause | Process design |
| Action | Omni sent an Urgent Medical Device Field Correction letter dated June 4, 2015 via email to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review inventory for affected product and complete and return the attached Acknowledgement and Receipt Form by FAX to 508-819-3390. |
| Quantity | 112 |
| Distribution | US Nationwide Distribution in the states of IL, VA, CO, UT, NY, FL, MA, OK, CA, TN and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112779 | APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM) Omnlife Science, Dec 2, 2011 |