Exact FDA event identifier

Event 80406

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

Open FDA event record

Event summary

Timeline bucket: May 18, 2018
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

OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cups are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis Rheumatoid arthritis Correction of functional deformity Congenital dislocation Revision procedures where other treatments or devices have failed

Z-2540-2018

Recall number: Z-2540-2018
Initiated: May 18, 2018
Classification: Class II
Status: Terminated
Recalling firm: OMNIlife science Inc.
Quantity: 16 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The Internal packaging, the pouch and patient labels are improperly labeled.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Internal packaging, the pouch and patient labels are improperly labeled.

Code information

Lot Numbers - 29147, 29148 & 29778

Distribution pattern

US Nationwide Distribution - in the states of AZ, CA, CO, IL, FL & MA