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U.S. Department of Health and Human Services

Class 2 Device Recall Optetrak Asymmetric HiFlex Posterior Stabilized Cemented Femorals, size 3

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  Class 2 Device Recall Optetrak Asymmetric HiFlex Posterior Stabilized Cemented Femorals, size 3 see related information
Date Initiated by Firm October 09, 2014
Date Posted January 05, 2015
Recall Status1 Terminated 3 on June 08, 2016
Recall Number Z-0906-2015
Recall Event ID 69466
510(K)Number K033883  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03.

Usage:Femoral implants
Code Information Catalog #244-02-03, Serial # 2925147 - 2925194; Catalog #244-03-0, Serial #2925246 - 2925293.
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Graham L. Cuthbert
352-377-1140
Manufacturer Reason
for Recall		 Mislabeled
FDA Determined
Cause 2		 Labeling mix-ups
Action The firm, Exactech, sent an "Urgent Field Safety Notice" letter dated September 30, 2014 to its Consignees/customers by electronic mail on October 9, 2014. The letter described the product, problem and actions to be taken. The customers were instructed to: immediately cease distribution or use of the products; extend information to your accounts that may have this product in their possession; verify whether you have any of the subject femoral components from the specified serial number ranges; complete and return the attached inventory RESPONSE FORM via fax to: 011 61 2 9638 0778 within 48 hrs of receipt of the notice, and contact your Exactech representative to confirm quantities at your location and arrangements for product return and inventory restocking. If you have any questions, contact Manager, Regulatory Affairs at 352-377-1140.
Quantity in Commerce 96
Distribution International Distribution only to countries of: Argentina, Austria, Australia, China, Cyprus, France, Greece, India, Japan, Lebanon, The Netherlands, Spain and Tunisia.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JWH and Original Applicant = EXACTECH, INC.
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