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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81472

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

Open FDA event record

Event summary

Timeline bucket
October 22, 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

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

Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126

Z-0495-2019
Recall number
Z-0495-2019
Initiated
October 22, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Label on the outer carton or the patient labels does not match label on the inner sterile packaging

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Label on the outer carton or the patient labels does not match label on the inner sterile packaging

Code information

Lot Number: J6255863 UDI: (01)00880304270794(17)280411(10)J6265594

Distribution pattern

AR, MO, MN, NJ, NY, OH, MN , NJ, VA

device · product 2 of 2

Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108

Z-0496-2019
Recall number
Z-0496-2019
Initiated
October 22, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
8 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Label on the outer carton or the patient labels does not match label on the inner sterile packaging

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Label on the outer carton or the patient labels does not match label on the inner sterile packaging

Code information

Lot Number: J6265594 UDI: (01)00880304270893(17)280411(10)J6255863

Distribution pattern

AR, MO, MN, NJ, NY, OH, MN , NJ, VA