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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66208

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

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Event summary

Timeline bucket
August 30, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Implantech Associates 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

Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region.

Z-2211-2013
Recall number
Z-2211-2013
Initiated
August 30, 2013
Classification
Class II
Status
Terminated
Recalling firm
Implantech Associates Inc
Quantity
8

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (Lot # 848488 and 850156), after determining that the devices from the lot numbers do not conform to the dimensional requirements for the TSCII-M.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (Lot # 848488 and 850156), after determining that the devices from the lot numbers do not conform to the dimensional requirements for the TSCII-M.

Code information

Catalog Number: TSCII-M Lot Numbers: 848488 and 850156

Distribution pattern

Worldwide distribution: US (nationwide) including states of NY, KY, and CO, and the country of Israel.