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Recall Observatory FDA recall evidence

Device product

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.

Z-2445-2015

June 04, 2015

Class II

Product summary

Firm
Omnilife Science Inc.
Event
Event 71461
Status
Terminated
Classification
Class II
Quantity
112
Official record key
device-enforcement:Z-2445-2015

Official wording

Reason: The device may have improper screw hole placement due to inaccurate location of the index line.

Code information: H5-12354: Lots - 20127 and 20167; H5-11356: Lot - 20097

Distribution pattern: US Nationwide Distribution in the states of IL, VA, CO, UT, NY, FL, MA, OK, CA, TN and WY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The device may have improper screw hole placement due to inaccurate location of the index line.

Field note

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