Exact FDA event identifier

Event 64465

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

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Event summary

Timeline bucket: February 01, 2013
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

Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.

Z-0953-2013

Recall number: Z-0953-2013
Initiated: February 01, 2013
Classification: Class II
Status: Terminated
Recalling firm: Exactech, Inc.
Quantity: 123 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A dimensional mismatch was identified which can potentially allow for interference between devices.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A dimensional mismatch was identified which can potentially allow for interference between devices.

Code information

Catalog # 02-012-42-3508 All lot numbers

Distribution pattern

Nationwide Distribution including the states of FL, AL, LA, PA, VA, IL, OH, NY, NC, KS, TN, NJ, CO, GA, CA, MD, MN, IN, & Puerto Rico.