Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82004

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

Open FDA event record

Event summary

Timeline bucket
December 21, 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 Series-A Standard Patella sizes 31mm Item Number: 184764

Z-0937-2019
Recall number
Z-0937-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
45 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.

Code information

Lot Number: 399960 UDI Number: (01)00880304431317(17)230302(10)399960

Distribution pattern

MN, VA Foreign: Korea, New Zealand and Japan

device · product 2 of 2

Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766

Z-0938-2019
Recall number
Z-0938-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
90 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.

Code information

Lot Number: 381800 UDI Number: (01)00880304434349(17)230301(10)381800 Lot NUmber: 400030 (01)00880304434349(17)230329(10)400030

Distribution pattern

MN, VA Foreign: Korea, New Zealand and Japan