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GMK Hinge knee prosthesis recallZ-0275-2016 · Medacta Usa · initiated Apr 17, 2015

Class II Terminated All recalls posted in November 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medacta Usa or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.

FDA root cause category: Employee error

What the company is doing

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: [email protected]

Recall details

Recall number
Z-0275-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 17, 2015
Posted by the FDA
Nov 14, 2015
Recalling firm
Medacta Usa
Quantity
4 units (US)
Product code
KRO
FDA submissions
K130299
Distribution
Distributed in the states of IL, OH and UT, and the countries of in Austria, Spain, Australia, France and Switzerland.

Product description

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

Code information (models, lots, serial numbers)

Lot: 145129

Other devices under the same FDA submission

55 devices cleared under K130299 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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