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U.S. Department of Health and Human Services

Class 2 Device Recall Optetrak Offset Tibial Tray and Screws

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 Class 2 Device Recall Optetrak Offset Tibial Tray and Screwssee related information
Date Initiated by FirmSeptember 19, 2017
Create DateNovember 20, 2017
Recall Status1 Terminated 3 on June 21, 2021
Recall NumberZ-0135-2018
Recall Event ID 78111
510(K)NumberK023186 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductOptetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.
Code Information All lot numbers
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information ContactGraham Cuthbert
352-377-1140
Manufacturer Reason
for Recall		There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
FDA Determined
Cause 2		Labeling design
ActionThe recalling firm issued a letter dated 9/19/2017 via email to their customers.
Quantity in Commerce733 devices
DistributionDistribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JWH
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