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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63412

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

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Event summary

Timeline bucket
December 12, 2011
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ormco/Sybronendo

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

Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.

Z-0205-2013
Recall number
Z-0205-2013
Initiated
December 12, 2011
Classification
Class II
Status
Terminated
Recalling firm
Ormco/Sybronendo
Quantity
4,543

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130¿C. The correct sterilization temperature should be listed as 132¿C and/or 270¿F.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130¿C. The correct sterilization temperature should be listed as 132¿C and/or 270¿F.

Code information

Part Numbers 601-0007 and 601-0010, all lots

Distribution pattern

Worldwide distribution, including Nationwide (USA) and the countries of Canada, Austria, Belgium, Bulgaria, Switzerland, Germany, Denmark, France, Estonia, Spain, Finland, Iceland, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Luxembourg, Netherlands, Monaco, Poland, Romania, Serbia, Slovenia, Turkey, Jersey, and Martinique.