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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86923

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

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Event summary

Timeline bucket
December 01, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
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

Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422

Z-0723-2021
Recall number
Z-0723-2021
Initiated
December 01, 2020
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
21 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure

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

Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure

Code information

Lot Number: 098780 UDI Number: (01) 00880304482739 (17) 290501 (10) 098780

Distribution pattern

Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Korea, Japan, Netherlands.