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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70304

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

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Event summary

Timeline bucket
January 22, 2015
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

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

GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical Kit, Complete, Catalog TSVKIT. Used as a manual delivery tool that engages the Fixture Mount Transfer (FMT) to transport the dental implant from the product packaging to the osteotomy.

Z-1115-2015
Recall number
Z-1115-2015
Initiated
January 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Dental Inc
Quantity
627 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant.

Code information

Etched Lot No. 62699693 & 62735177. Lot Number on Label: 62712431, 62743168, 62766610, 62702589, 62710484, 62712437, 62743075, 62750487, 62753787, 62756920, 62759862, 62760388, 62768456, and 62773158. Expanded Lot No. 62728173.

Distribution pattern

Worldwide Distribution -- US, Argentina, Australia, Bulgaria, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, Iran, Israel, Italy, Japan, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Pakistan, Panama, Poland, Romania, Russia, Saudi Arabia, Serbia, Taiwan, Thailand, Tunisia, Turkey, and UAE. Expanded Distribution: Spain

Field note

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