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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88917

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

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Event summary

Timeline bucket
October 11, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Jjgc Industria E Comercio De Materials Dentarios Sa

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

GM Helix Acqua Implant 3.5x10, Article No. 140.944

Z-0203-2022
Recall number
Z-0203-2022
Initiated
October 11, 2021
Classification
Class II
Status
Terminated
Quantity
567 (US)

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 · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.

Code information

UDI 7899878024897 Lots GNW15 and GRE82

Distribution pattern

US Nationwide distribution.