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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96806

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 01, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Straumann 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

2 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 2

GM Helix Acqua Implant, Article Number: 140.984

Z-1862-2025
Recall number
Z-1862-2025
Initiated
May 01, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Straumann USA LLC
Quantity
300 units (125 US, 175 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.

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

It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.

Code information

Article Number: 140.984; UDI-DI: (01)7899878025290(11)220122(17)260121(10)JPZ21; Lot number: JPZ21;

Distribution pattern

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, Il KS, LA, MA, MD, MI, NE, NH, NJ, NY, OH, OK, RI, SC, TN, TX, UT, WI and the countries of Australia, Croatia, France, Hungary, India, Italy, Lebanon, Lithuania, New Zealand, Portugal, Qatar, Serbia, Spain, Tunisia, UAE, United Kingdom, Vietnam.

device · product 2 of 2

GM Helix Acqua Implant, Article Number: 140.985

Z-1863-2025
Recall number
Z-1863-2025
Initiated
May 01, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Straumann USA LLC
Quantity
207 units (54 US, 153 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.

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

It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.

Code information

Article Number: 140.985; UDI-DI: (01)7899878024569(11)220125(17)270124(10)JPZ75; Lot number: JPZ75;

Distribution pattern

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, Il KS, LA, MA, MD, MI, NE, NH, NJ, NY, OH, OK, RI, SC, TN, TX, UT, WI and the countries of Australia, Croatia, France, Hungary, India, Italy, Lebanon, Lithuania, New Zealand, Portugal, Qatar, Serbia, Spain, Tunisia, UAE, United Kingdom, Vietnam.