Exact FDA event identifier

Event 82653

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

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Event summary

Timeline bucket: March 31, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Integra Limited

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

Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehiscence) and diabetic ulcers of both partial and full-thickness varieties. The device is intended for one-time use.

Z-1338-2019

Recall number: Z-1338-2019
Initiated: March 31, 2019
Classification: Class II
Status: Terminated
Recalling firm: Integra Limited
Quantity: 274 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months

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

Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months

Code information

Lot Code: 2991332

Distribution pattern

Worldwide Distribution - US Nationwide Foreign; Peru, Ecuador, Columbia, Brazil