Z-2234-2012 Class II Terminated
FDA device recall Z-2234-2012 was initiated by Exactech, Inc. on Oct 17, 2011 and is designated Class II. Reason for recall: Exactech, Inc. of Gainesville, FL recalled their Optetrak Proximal Tibial Spacer after the devices were determined to be dimensionally incompatible to mate as intended with the Logic Tibial Tray. The recall status is terminated (terminated Nov 7, 2013). Affected quantity: 70.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 29, 2012
- Initiation Date
- Oct 17, 2011
- Termination Date
- Nov 7, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70
Product Description
OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Components. REF 02--012-42-2508. The Optetrak Comprehensive Knee Systems are 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. The Optetrak Comprehensive Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and patients whose weight, age, or activity level might cause extreme loads and early failure of the system.
Reason for Recall
Exactech, Inc. of Gainesville, FL recalled their Optetrak Proximal Tibial Spacer after the devices were determined to be dimensionally incompatible to mate as intended with the Logic Tibial Tray.
Distribution Pattern
Nationwide distribution: USA including states of: AL, AZ, CO, FL, GA, IL, LA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TN, VA, and WA.
Code Information
Catalog Number: 02-012-42-2508.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2234-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026