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U.S. Department of Health and Human Services

Class 2 Device Recall Medacta GMK HINGE, Tibial Insert Fixed

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  Class 2 Device Recall Medacta GMK HINGE, Tibial Insert Fixed see related information
Date Initiated by Firm May 19, 2017
Date Posted June 12, 2017
Recall Status1 Terminated 3 on May 29, 2018
Recall Number Z-2661-2017
Recall Event ID 77467
510(K)Number K130299  
Product Classification Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
Product Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
Code Information Lot # 163646
Recalling Firm/
Manufacturer
Medacta Usa Inc
3973 Delp St
Memphis TN 38118-6110
For Additional Information Contact Customer Service
312-878-2381
Manufacturer Reason
for Recall
One lot of product does not include a screw for attachment to the tibial base plate.
FDA Determined
Cause 2
Nonconforming Material/Component
Action On 5/19/17 all distributors with recalled product were immediately notified of the recall by email. On 5/23/17, all distributors were further notified of the recall via phone. On 5/30/17, a third notification was completed via phone.
Quantity in Commerce 4 units
Distribution CA, AZ, NC, Israel, France
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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