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The GMK knee system: designed for cemented use in total… recallZ-0266-2018 · Medacta Usa Inc · initiated Oct 24, 2017

Class II Terminated All recalls posted in December 2017

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 Inc 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

Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%. For this reason, we stress the importance of using the 3.5 Nm torque limiting driver if the screw is used, as directed in our surgical techniques.

FDA root cause category: Device Design

What the company is doing

All surgeon customers shall be notified via email by October 24, 2017 of the reminder to follow the surgical technique. To ensure that surgeons receive the notification, we will send the letter via email so that we can track and ensure the message was received. If the email is returned, we would then send a personalized letter directly to the surgeon. A copy of this notification is included with the submission of this report.

Recall details

Recall number
Z-0266-2018
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 24, 2017
Posted by the FDA
Dec 20, 2017
Recalling firm
Medacta Usa Inc
Quantity
12,768 units
Product code
JWH
FDA submissions
K090988
Distribution
nationwide

Product description

The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF

Code information (models, lots, serial numbers)

all serial numbers

Other devices under the same FDA submission

81 devices cleared under K090988 — 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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