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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85958

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

Open FDA event record

Event summary

Timeline bucket
June 18, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Anjon Holdings

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

Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.

Z-2778-2020
Recall number
Z-2778-2020
Initiated
June 18, 2020
Classification
Class II
Status
Terminated
Recalling firm
Anjon Holdings
Quantity
249 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
High rate of galling of one threaded component.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

High rate of galling of one threaded component.

Code information

REF number 100048 Lot # 170240, US customer Lot # 170162, 170163, 70164,170165, 170229, 170240, 170247, 170260 and SM 42048. International customers.

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the state of MI and the country of Japan for training purposes.