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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74782

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

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Event summary

Timeline bucket
July 20, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Nobel Biocare Usa Llc

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

Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided Surgery Kit. The Guided Surgery Kit is used as part of the installation process of NobelParallel CC Implants. The purpose of the IFU is to instruct the user how to use the products safely. The purpose of the manual is to guide the user through the usage of NobelGuide for NobelParallel CC.

Z-2375-2016
Recall number
Z-2375-2016
Initiated
July 20, 2016
Classification
Class II
Status
Terminated
Recalling firm
Nobel Biocare Usa Llc
Quantity
231 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect drill protocol in the Instructions for Use (IFU)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect drill protocol in the Instructions for Use (IFU)

Code information

Article 38072-all lots

Distribution pattern

Worldwide Distribution: US (nationwide) and Countries of: Austria, Belgium, Canada, Germany, Denmark, Spain, France, Great Britain, Italy, Netherlands, Norway, Poland, Portugal, Russia, and Turkey.