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U.S. Department of Health and Human Services

Class 2 Device Recall GMK Intramedullary Extension Rod 100 mm

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  Class 2 Device Recall GMK Intramedullary Extension Rod 100 mm see related information
Date Initiated by Firm September 22, 2014
Date Posted November 12, 2014
Recall Status1 Terminated 3 on May 07, 2015
Recall Number Z-0202-2015
Recall Event ID 69493
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement.
Rod to obtain correct leg alignment during total knee replacement.
Code Information Model Number: 02.07.10.0162
Recalling Firm/
Manufacturer		 Medacta Usa
1552 W Carroll Ave
Chicago IL 60607-1012
For Additional Information Contact Mr. Adam Gross
805-910-6511
Manufacturer Reason
for Recall		 Medacta has registered in its database 3 cases of breakage of the GMK Intramedullary Extension Rod 100 mm, code 02.07.10.0162.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Medacta sent an URGENT MEDICAL DEVICE letter dated September 22, 2014 to the sole US consignee. The letter included instructions for the consignee to: 1) check its inventory of the device; 2) quarantine and do not use the recalled device; and, 3) return the recalled device upon receipt of a RMA # from the Medacta QA Department. For questions regarding this recall call 805-910-6511.
Quantity in Commerce 1 rod (US); 145 rods (global)
Distribution Worldwide Distribution - US including OH and Internationally to Australia, Austria, Belgium, France, Germany, Greece, Italy, Japan, Portugal, South Africa, Spain, 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.
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