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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79818

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 16, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DePuy Orthopaedics, 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

2 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 2

ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee

Z-1703-2018
Recall number
Z-1703-2018
Initiated
April 16, 2018
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There may be burrs on the extraction hole threads.

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

There may be burrs on the extraction hole threads.

Code information

Lot Number HC1179, GTIN Number 10603295042181; Lot Number HC1183, GTIN Number 10603295042181

Distribution pattern

The products were distributed to the following US states: FL, MO, and PA.

device · product 2 of 2

ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee

Z-1704-2018
Recall number
Z-1704-2018
Initiated
April 16, 2018
Classification
Class II
Status
Terminated
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There may be burrs on the extraction hole threads.

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

There may be burrs on the extraction hole threads.

Code information

Lot Number HD6516, GTIN Number 10603295042280

Distribution pattern

The products were distributed to the following US states: FL, MO, and PA.