Exact FDA event identifier

Event 98376

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

Event summary

Timeline bucket: February 03, 2026
Product types: Device
Classifications: Class II
Statuses: Ongoing
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

Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05

Z-1509-2026

Recall number: Z-1509-2026
Initiated: February 03, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Exactech, Inc.
Quantity: 120 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Impactor handle may be missing cross-pin

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

Impactor handle may be missing cross-pin

Code information

Lot Code: Part Number: 321-09-05 UDI-DI: 10885862557674 Lot Number: All (Please refer to Attachment 1 - Product Information Spreadsheet for details)

Distribution pattern

US: CA CO FL GA HI ID IL IN KS KY LA MA MD ME MN NV NY OH OK PR SC TN TX VA WI OUS: Australia France Germany Italy Japan Korea Spain Switzerland United Kingdom United Arab Emirates Slovenia

device · product 2 of 2

Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X

Z-1510-2026

Recall number: Z-1510-2026
Initiated: February 03, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Exactech, Inc.
Quantity: 596 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Impactor handle may be missing cross-pin

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

Impactor handle may be missing cross-pin

Code information

All Lots/ UDI-DI: 10885862559166

Distribution pattern

US: CA CO FL GA HI ID IL IN KS KY LA MA MD ME MN NV NY OH OK PR SC TN TX VA WI OUS: Australia France Germany Italy Japan Korea Spain Switzerland United Kingdom United Arab Emirates Slovenia