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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79855

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

Open FDA event record

Event summary

Timeline bucket
March 03, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Implant Direct Sybron Manufacturing, LLC

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

ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

Z-2551-2018
Recall number
Z-2551-2018
Initiated
March 03, 2017
Classification
Class II
Status
Terminated
Quantity
124 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label lists the incorrect

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 main vial label lists the incorrect part number, but the cap label is correct.

Code information

Lot #87837

Distribution pattern

Distribution was made to AZ, CA, CO, CT, FL, ID, IL, NC, NJ, NV, NY, PA, TX, UT, VA, and WA. There was no government/military distribution. Foreign distribution was made to Switzerland, Germany, Lithuania, and Spain.