Reported May 1, 2019 · Terminated

Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint…

Exactech, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Exactech, Inc. · 2320 NW 66th Ct · Gainesville, FL · 32653-1630

Is this the product you have?

  • Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog
  • Number 02-022-45-3030 Product UsageKnee 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
Lot codes and dates
  • Serial Numbers
    • 5774515
    • 5774517
    • 5774518
    • 5774519
    • 5774520
    • 5774521
    • 5774525
    • 5774526
    • 5774527
    • 5774529
    • 5774531
    • 5774532
    • 5774533
    • 5774534
    • 5774535
    • 5774541
    • 5774543
Amount recalled
18 units

Where it was sold

Why it was recalled

2.5 Truliant Fit Trays were mismarked as 3

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 22, 2021 · Data as of Sep 19, 5:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.