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Exactech, Inc. recalls OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Ti
Recalled September 12, 2012 · FDA recall Z-2310-2012 · Exactech
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. · FDA Class II
Units
193
Sold at
USA ( nationwide) WA, OH, OK, TX, NC, NY, CO, VA, MA, IL, TN, MN, NJ and FL.
Description
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
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.
Manufacturer(s)
Exactech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →