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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88282

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

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Event summary

Timeline bucket
May 27, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
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

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

Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.

Z-2198-2021
Recall number
Z-2198-2021
Initiated
May 27, 2021
Classification
Class II
Status
Terminated
Recalling firm
Straumann USA LLC
Quantity
130 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not properly fit the opposing screw head and cannot pick up the screws, may result in injury

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

Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not properly fit the opposing screw head and cannot pick up the screws, may result in injury

Code information

Packaged lot number: EHG85 Lot Number engraved on part: CXV34

Distribution pattern

US Nationwide Distribution