Exact FDA event identifier

Event 78064

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: July 11, 2017
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

1 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 1

Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool

Z-0603-2018

Recall number: Z-0603-2018
Initiated: July 11, 2017
Classification: Class II
Status: Terminated
Recalling firm: Exactech, Inc.
Quantity: 41 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Vix Bit may fracture during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Vix Bit may fracture during use.

Code information

Catalog No. 531-15-08, Lot No. 75296003, 80129003, 81327001

Distribution pattern

Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom.