U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Incorrect parts: packages of the gmk hinge tibial augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.
조치
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