Recall Z-2234-2012 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Exactech, Inc.
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-tr
| Date | Aug 21, 2012 (initiated Oct 17, 2011) |
| Status | Terminated |
| Reason | 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 | Device Design |
| Action | 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 representa |
| Quantity | 70 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071738 | EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER Exactech, Inc., Aug 15, 2007 |