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U.S. Department of Health and Human Services

Class 2 Device Recall Medacta

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  Class 2 Device Recall Medacta see related information
Date Initiated by Firm April 17, 2015
Date Posted November 14, 2015
Recall Status1 Terminated 3 on January 05, 2017
Recall Number Z-0275-2016
Recall Event ID 71121
510(K)Number K130299  
Product Classification Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
Product GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
Code Information Lot: 145129
Recalling Firm/
Manufacturer		 Medacta Usa
1556 W Carroll Ave
Chicago IL 60607-1012
For Additional Information Contact Mr. Mike Loiterman
312-548-9971
Manufacturer Reason
for Recall		 Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.
FDA Determined
Cause 2		 Employee error
Action On 4/16/15 all distributors with recalled product were immediately notified of the recall by phone. On 4/20/15, all distributors were further notified of the recall via email. The URGENT MEDICAL DEVICE RECALL letter dated 4/17/2015 the firm described the initiation of a recall for regarding the GMK HINGE Tibial Augmentation Size 4-10mm Reference 02.09TA410 / Lot 145129. The firm provided the following recall actions to be performed: 1.Check your inventory for the device listed above. If you find it, IMMEDIATELY place it in quarantine and DO NOT use it in surgery. 2.If you have further distributed this device to other customers please notify me and initiate their return to Medacta USA. 3.We will provide you with an update on a replacement within the next few days. The firm also provided a contact for customers requiring additional information. Mike Loiterman Director of Regulatory, Quality and Compliance Medacta USA Phone: 312548-9971Fax: 312-546-6881MLoiterman@medacta.us.com
Quantity in Commerce 4 units (US)
Distribution Distributed in the states of IL, OH and UT, and the countries of in Austria, Spain, Australia, France and Switzerland.
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 = KRO and Original Applicant = MEDACTA INTERNATIONAL
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