FDAFDA · Food and drugs·Recall number Z-2310-2012
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.
Published September 12, 2012 · Recall initiated: August 19, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Exactech, Inc.
- Distributor
- USA ( nationwide) WA, OH, OK, TX, NC, NY, CO, VA, MA, IL, TN, MN, NJ and FL.
- Lot
- Catalog numbers 02-012-35-6011, 02-012-35-6013, 02-012-35-6015 All lots.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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