Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86590

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

Open FDA event record

Event summary

Timeline bucket
September 25, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Exactech, 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

Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.

Z-0307-2021
Recall number
Z-0307-2021
Initiated
September 25, 2020
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
25 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.

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

The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.

Code information

Catalog: 304-21-07; Serial Ranges: 4968615-4968627; 4952421-4952432

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico. The countries of Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, UK, Luxembourg, and Brazil.

device · product 2 of 2

Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.

Z-0308-2021
Recall number
Z-0308-2021
Initiated
September 25, 2020
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
12 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.

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

The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.

Code information

Catalog: 304-22-07; Serial Range: 4971292-4971303

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico. The countries of Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, UK, Luxembourg, and Brazil.