FDAFDA · Alimentos y medicamentos·N.º oficial 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.
Publicado el 12 de septiembre de 2012 · Inicio del retiro: 19 de agosto de 2011
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Exactech, Inc.
- Distribuidor
- USA ( nationwide) WA, OH, OK, TX, NC, NY, CO, VA, MA, IL, TN, MN, NJ and FL.
- Lote
- Catalog numbers 02-012-35-6011, 02-012-35-6013, 02-012-35-6015 All lots.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States