GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery

FDA device recall Z-0275-2016 · posted 2015-11-14 · Terminated

Recall details

Recalling firm

Medacta Usa

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.

Action taken

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

Root cause

Employee error

Status

Terminated

Product code

KRO

Quantity affected

4 units (US)

Distribution

Distributed in the states of IL, OH and UT, and the countries of in Austria, Spain, Australia, France and Switzerland.

Date initiated

2015-04-17

Date posted

2015-11-14

Date terminated

2017-01-05

Location

Chicago, IL

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