Exact FDA event identifier

Event 75499

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

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Event summary

Timeline bucket: October 14, 2016
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: OMNI LIFE 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

OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty

Z-0610-2017

Recall number: Z-0610-2017
Initiated: October 14, 2016
Classification: Class III
Status: Terminated
Recalling firm: OMNI LIFE SCIENCE
Quantity: 15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incorrect lot number on outer kit

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect lot number on outer kit

Code information

Lot number: 19-09-021

Distribution pattern

Worldwide Distribution: US distribution to OK, MD, TX and country of: Australia.