—#109896

Product

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.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K071738
Affected lot / code info: Catalog Number: 02-012-42-2508.

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

The firm, Exactech, Inc., sent a "IMPORTANT PRODUCT RECALL NOTICE" date October 17, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to immediately cease distribution or use of these products; extend this information to their accounts that may have possession of this product; verify if they have any of the subject Logic size 2.5 Proximal Tibial Spacer products, complete and return the attached PRODUCT RECALL FAX NOTICE form within five (5) working days via fax to: 352-337-3915, and to contact the firm inventory representative to confirm quantities at the location. For questions regarding inventory restocking, please call 1-800-392-2832.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

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.

Timeline

Recall initiated: 2011-10-17
Posted by FDA: 2012-08-21
Terminated: 2013-11-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #109896. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.