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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86733

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

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Event summary

Timeline bucket
November 04, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
K2M, 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

Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT screw by rocking the instrument back and forth until the entire tab is fully detached from the screw head. Catalog number: 5101-90195

Z-0542-2021
Recall number
Z-0542-2021
Initiated
November 04, 2020
Classification
Class II
Status
Terminated
Recalling firm
K2M, Inc
Quantity
197 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between tool s metal shaft component and handle, resulting in leakage of Loctite from handle cracks

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

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Inspect official wording and provenance

Reason for recall

All-in-One Tab Removal Tool may cause cracking and/or separating at the threaded interface between tool s metal shaft component and handle, resulting in leakage of Loctite from handle cracks

Code information

Lot Numbers: JUFT, JUGX, KEFE, KUBJ, KVNT, KYRR, MAJR GTIN: 10888857290679

Distribution pattern

Nationwide Foreign: Netherlands, Spain, UK, Belgium, Germany, Italy, Norway and Sweden