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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82480

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

Open FDA event record

Event summary

Timeline bucket
March 13, 2019
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

Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.

Z-1208-2019
Recall number
Z-1208-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
2.5 Truliant Fit Trays were mismarked as 3

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

2.5 Truliant Fit Trays were mismarked as 3

Code information

Serial Numbers: 5774515, 5774517, 5774518, 5774519, 5774520, 5774521, 5774525, 5774526, 5774527, 5774529, 5774531, 5774532, 5774533, 5774534, 5774535, 5774541, 5774543

Distribution pattern

US Nationwide Distribution in the states of AR, CA, OH, OK, IN, MN, NJ, TN, SC, FL