CLASS II Device recall · Reported 12 Sep 2012 · FDA Enforcement Report

Optetrak Logic Tibial Insert Posterior Stabilized***Match recalled

Exactech is recalling Optetrak Logic Tibial Insert Posterior Stabilized***Match Component Colors 6 Yellow, Use, distributed nationwide in the US. The recall was initiated on 19 Aug 2011 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog numbers 02-012-35-6011, 02-012-35-6013, 02-012-35-6015 All lots.

Quantity recalled193

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2310-2012
FDA event ID: 61984
Recalling firm: Exactech, Gainesville, FL
Classification: Class II
Status: Terminated
Recall initiated: 19 Aug 2011
FDA classified: 4 Sep 2012
Reported: 12 Sep 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

19 Aug 2011	Recall initiated by company
4 Sep 2012	Classified by FDA	+382 days
12 Sep 2012	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Exactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial Insert, Size 6 after the device was determined to be out of dimensional specification.

Product as listed by the FDA

OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three product sizes being recalled, 11mm, 13mm, 15mm. All other information is the same. The Optetrak Logic Total Knee System is 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. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

Where it was distributed

USA ( nationwide) WA, OH, OK, TX, NC, NY, CO, VA, MA, IL, TN, MN, NJ and FL.

Nationwide Colorado Florida Illinois Massachusetts Minnesota North Carolina New Jersey New York Ohio Oklahoma Tennessee Texas Virginia Washington

Questions about this recall

Is Optetrak Logic Tibial Insert Posterior Stabilized***Match Component Colors 6 Yellow, Use recalled?

Yes. Exactech recalled Optetrak Logic Tibial Insert Posterior Stabilized***Match Component Colors 6 Yellow, Use on 19 Aug 2011. The recall is Class II and its status is Terminated. Recall number Z-2310-2012.

Why was it recalled?

Exactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial Insert, Size 6 after the device was determined to be out of dimensional specification.

Which lots are affected?

Catalog numbers 02-012-35-6011, 02-012-35-6013, 02-012-35-6015 All lots.

Where was it sold?

USA ( nationwide) WA, OH, OK, TX, NC, NY, CO, VA, MA, IL, TN, MN, NJ and FL.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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