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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79066

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

Open FDA event record

Event summary

Timeline bucket
June 16, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Keystone Dental 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

Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or lower jaw.

Z-0718-2018
Recall number
Z-0718-2018
Initiated
June 16, 2017
Classification
Class II
Status
Terminated
Recalling firm
Keystone Dental Inc
Quantity
72

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.

Code information

Catalog Number D-TAP-MAX7-7, Lot 31444

Distribution pattern

USA (nationwide) Distribution to the states of : CA, CO, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NY, OH, PA, TN, TX, UT, VA, VT, WA, WI and WV; and Internationally to Canada