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.
FDA Recall Z-2445-2015 · Posted 2015-08-21
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Recalling FirmOmnilife Science Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2015-06-04
Date Terminated2015-09-28
Product Quantity112
Reason for Recall
The device may have improper screw hole placement due to inaccurate location of the index line.
Firm 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.
Root Cause
Process design
Distribution Pattern
US Nationwide Distribution in the states of IL, VA, CO, UT, NY, FL, MA, OK, CA, TN and WY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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