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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92084

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

Open FDA event record

Event summary

Timeline bucket
March 31, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Ethicon, 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

PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H

Z-1571-2023
Recall number
Z-1571-2023
Initiated
March 31, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Ethicon, Inc.
Quantity
1,656 eaches (OUS only)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved

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

Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved

Code information

UDI-DI: (01)10705031124691 Primary (Individual Unit); (01)30705031124695 (Sales Unit Box) Qty = 36 eaches. Lot Number: SCMAZH

Distribution pattern

International distribution in the countries of United Kingdom, Ireland and Turkey.