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U.S. Department of Health and Human Services

Enforcement Report - Week of August 29, 2012
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Event Detail

Event ID 62134
Product Type Devices
Status Ongoing
Recalling Firm Exactech, Inc.
City Gainesville
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-10-17
Initial Firm Notification of
Consignee or Public		 Letter
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Catalog Number: 02-012-42-2508. Class II 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. 70 Z-2234-2012
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