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U.S. Department of Health and Human Services

Class 2 Device Recall OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED

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 Class 2 Recall
OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED
see related information
Date Posted September 04, 2012
Recall Status1 Terminated on November 07, 2013
Recall Number Z-2310-2012
Recall Event ID 61984
Premarket Notification
510(K) Number
K093360 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product 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.
Code Information Catalog numbers 02-012-35-6011, 02-012-35-6013, 02-012-35-6015 All lots.
Recalling Firm/
Manufacturer
Exactech, Inc.
2320 NW 66th Ct
Gainesville, Florida 32653-1630
For Additional Information Contact Graham L. Cuthbert
352-377-1140
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Exactech, Inc., sent an "IMPORTANT PRODUCT MARKET WITHDRAWAL NOTICE" letter dated August 19, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to: 1. Immediately cease distribution or use of the products. 2. Extend the information to accounts that are in possession of the products. 3. Verify if they had any of the affected products on the list. 4. Fax back the attached form. In addition, they were instructed to contact the Exactech inventory representative to confirm quantities at their location. If you have any questions regarding inventory restocking issue, please call -800-392-2832.
Quantity in Commerce 193
Distribution USA ( nationwide) WA, OH, OK, TX, NC, NY, CO, VA, MA, IL, TN, MN, NJ and FL.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = EXACTECH, INC.
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