Z-0266-2018Class II

The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with...

Name: Z-0266-2018 The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with...
Creator: Medacta Usa Inc
Published: 2017-10-24
License: https://open.fda.gov/license/

Medacta USA, Inc. / initiated 2017-10-24 / Terminated / root cause: design

FDA source

Medacta Usa Inc began a recall of 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... on 2017-10-24. FDA classified it as Class II and gives the reason as "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 of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0266-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-24
Posted: 2017-12-20
Terminated: 2018-06-20
Recalling firm: Medacta USA, Inc.
Product: 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
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 12,768 units
Distribution: nationwide
Product codes and lots: all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0266-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0266-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-27	2017-12-20

Product code JWH

K090988Class IIGmk Total Knee SystemMedacta International S.A. / cleared 2009-07-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)