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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79117

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

Open FDA event record

Event summary

Timeline bucket
August 31, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DePuy Mitek, Inc., a Johnson & Johnson Co.

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

1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.

Z-0695-2018
Recall number
Z-0695-2018
Initiated
August 31, 2017
Classification
Class II
Status
Terminated
Quantity
15,678

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Leakage of FMS gravity tub sets (281113) at the bulb and tube connection

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Leakage of FMS gravity tub sets (281113) at the bulb and tube connection

Code information

Lot codes: 138, 194, 633, 1067, 1741, 2576, 2608, and 2645

Distribution pattern

US Nationwide Distribution