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U.S. Department of Health and Human Services

Class 2 Device Recall Proximal Tibial Spacer

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 Class 2 Recall
Proximal Tibial Spacer
see related information
Date Posted March 15, 2013
Recall Status1 Terminated on September 22, 2014
Recall Number Z-0953-2013
Recall Event ID 64465
Premarket Notification
510(K) Number
K071738 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
Code Information Catalog # 02-012-42-3508 All lot numbers
Recalling Firm/
Manufacturer
Exactech, Inc.
2320 NW 66th Ct
Gainesville, Florida 32653-1630
Manufacturer Reason
for Recall
A dimensional mismatch was identified which can potentially allow for interference between devices.
FDA Determined
Cause 2
DESIGN: Device Design
Action Exactech Inc. sent a *** Important *** Product Market Recall Notice dated January 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Customers were instructed to immediately cease distribution or use of these products. 2. Extend this information to your accounts that may have this product in their possession. 3. Verify if you have any of the subject Optetrak Logic Proxima Tibial Spacer (PTS) in the specified lots. Please complete the attached fax back form and return it to Exactech within the next 5 working days. Thank you for your prompt attention to this matter. For further questions please call (352) 377-1140.
Quantity in Commerce 123 devices
Distribution Nationwide Distribution including the states of FL, AL, LA, PA, VA, IL, OH, NY, NC, KS, TN, NJ, CO, GA, CA, MD, MN, IN, & Puerto Rico.
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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