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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81604

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

Open FDA event record

Event summary

Timeline bucket
October 31, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zimmer Biomet, 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

NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment Block is used when femoral components can neither be downsized nor can be distally augmented by increasing the thickness of the cement mantle.

Z-0630-2019
Recall number
Z-0630-2019
Initiated
October 31, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
19 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Screw is missing from the package

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

Screw is missing from the package

Code information

Lot Number: 62925336 UDI Number: (01)00889024224131(17)250228(10)62925336

Distribution pattern

Worldwide Distribution: US (nationwide) to states of: OH, FL, NJ, NY, OH, PA, TX, WV and to countries of: CANADA, AUSTRALIA, JAPAN, GERMANY, and NETHERLANDS.