Z-2310-2012 Class II Terminated
FDA device recall Z-2310-2012 was initiated by Exactech, Inc. on Aug 19, 2011 and is designated Class II. 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. The recall status is terminated (terminated Nov 7, 2013). Affected quantity: 193.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 12, 2012
- Initiation Date
- Aug 19, 2011
- Termination Date
- Nov 7, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 193
Product Description
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.
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.
Distribution Pattern
USA ( nationwide) WA, OH, OK, TX, NC, NY, CO, VA, MA, IL, TN, MN, NJ and FL.
Code Information
Catalog numbers 02-012-35-6011, 02-012-35-6013, 02-012-35-6015 All lots.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2310-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026