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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91280

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

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Event summary

Timeline bucket
December 02, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Integra LifeSciences Corp.

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

Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457

Z-0909-2023
Recall number
Z-0909-2023
Initiated
December 02, 2022
Classification
Class II
Status
Ongoing
Quantity
168 US; 3 OUS

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out-of-specification

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

Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.

Code information

UDI-DI 10381780514961 Lot Number: 6396457 Expiration date 06/30/2027

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of CA, CO, CT, FL, IN, KY, MA, MI, MO, NC, NJ, NY, OH, PA, TX, VA, WV and the countries of Chile, Australia, New Zealand, France, Romania, United Kingdom, and Ireland.