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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78667

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 29, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zimmer 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

2 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 2

Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.

Z-1189-2018
Recall number
Z-1189-2018
Initiated
November 29, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Dental Inc
Quantity
995 distribution events total

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.

Code information

Lot No. 63621027, UDI #(01)00889024019928 (17)220331 (10)63619437.

Distribution pattern

Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.

device · product 2 of 2

Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.

Z-1190-2018
Recall number
Z-1190-2018
Initiated
November 29, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Dental Inc
Quantity
995 distribution events total

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.

Code information

Lot No. 63619437, UDI #(01)00889024019225 (17)220331 (10)63619437.

Distribution pattern

Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.