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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85981

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

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Event summary

Timeline bucket
June 24, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Smith & Nephew, Inc.

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

SUTUREFIX ULTRA Suture, Product number 72203855

Z-2746-2020
Recall number
Z-2746-2020
Initiated
June 24, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Smith & Nephew, Inc.
Quantity
868

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
packaging error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.

Code information

Lot numbers 2038366, 2039311 and 2046505

Distribution pattern

Domestic distribution to AL AR AZ CO GA IL IN KS KY MD MN MO NC NE NJ NY OK PA PR TN TX VA WI. Foreign distribution to Australia Austria Belgium Finland France Germany Great Britain Ireland Italy Japan Luxembourg Mexico Netherlands Poland Portugal Singapore South Africa Spain Sweden Switzerland