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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88890

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

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Event summary

Timeline bucket
October 01, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
OmniLife Science

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 K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.

Z-0237-2022
Recall number
Z-0237-2022
Initiated
October 01, 2021
Classification
Class II
Status
Terminated
Recalling firm
OmniLife Science
Quantity
7

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.

Code information

UDI 00841690102496 Lot 38933

Distribution pattern

US Distribution to states of: Colorado and Virginia.