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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84673

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

Open FDA event record

Event summary

Timeline bucket
December 27, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Wright Medical Technology, 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

WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220

Z-1101-2020
Recall number
Z-1101-2020
Initiated
December 27, 2019
Classification
Class II
Status
Terminated
Quantity
39 devices

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label and laser marking are incorrect

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

Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.

Code information

Lot Code 1633010

Distribution pattern

US

device · product 2 of 2

WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222

Z-1102-2020
Recall number
Z-1102-2020
Initiated
December 27, 2019
Classification
Class II
Status
Terminated
Quantity
48 devices

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label and laser marking are incorrect

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

Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.

Code information

Lot code 1633303

Distribution pattern

US