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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95828

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

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Event summary

Timeline bucket
November 22, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
3M Company - Health Care Business

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

Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833 359-834 359-835 359-836 359-837

Z-0743-2025
Recall number
Z-0743-2025
Initiated
November 22, 2024
Classification
Class II
Status
Ongoing
Quantity
171 orders

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Attachments may not mate with the tooth as intended in the digital treatment design.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design (manufacturing process)

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Attachments may not mate with the tooth as intended in the digital treatment design.

Code information

Only 3M Clarity Precision Grip Attachment Dual Arch Attachments are potentially affected. Part numbers/UDI-DI: 359-830/ 00652221307286; 359-831/ 00652221307293; 359-832/00652221307309; 359-833/ 00652221307316; 359-834/ 00652221307361; 359-835/ 00652221307378; 359-836/ 00652221307385; 359-837/ 00652221307392

Distribution pattern

Product was distributed nationwide US, and internationally to Canada, Australia, and New Zealand.