Exact FDA event identifier

Event 83794

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

Open FDA event record

Event summary

Timeline bucket: October 26, 2018
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

Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant

Z-0363-2020

Recall number: Z-0363-2020
Initiated: October 26, 2018
Classification: Class II
Status: Terminated
Recalling firm: Implant Direct Sybron Manufacturing, LLC
Quantity: 53 implants

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

packaging error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.

Code information

Lot numbers 120197; Exp. 07/16/2023 and 120198; Exp. 07/19/2023

Distribution pattern

US distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO,