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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84639

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

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Event summary

Timeline bucket
January 03, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
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

Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.

Z-0989-2020
Recall number
Z-0989-2020
Initiated
January 03, 2020
Classification
Class II
Status
Terminated
Recalling firm
Ethicon, Inc.
Quantity
23688 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.

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

Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.

Code information

lot PGZ908

Distribution pattern

Domestic distribution nationwide. US and Puerto Rico only.