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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71461

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 04, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Omnilife Science Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-2445-2015
Initiated
June 04, 2015
Classification
Class II
Status
Terminated
Recalling firm
Omnilife Science Inc.
Quantity
112

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The device may have improper screw hole placement due to inaccurate location of the index line.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.