Recall Z-0266-2018— Medacta Usa Inc

Name: FDA recall Z-0266-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-24

Class II · Terminated

Class II FDA medical device recall by Medacta Usa Inc, initiated 2017-10-24, terminated 2018-06-20. It names one FDA 510(k) clearance: K090988. 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. Reason: 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..

Recalling firm: Medacta Usa Inc
Classification: Class II
Status: Terminated
Initiated: 2017-10-24
Terminated: 2018-06-20
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K090988 — GMK TOTAL KNEE SYSTEMMedacta International S.A.·cleared 2009-07-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.