Recall Z-2661-2017— Medacta Usa Inc

Name: FDA recall Z-2661-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-19

Class II · Terminated

Class II FDA medical device recall by Medacta Usa Inc, initiated 2017-05-19, terminated 2018-05-29. It names one FDA 510(k) clearance: K130299. Product: Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO. Reason: One lot of product does not include a screw for attachment to the tibial base plate..

Recalling firm: Medacta Usa Inc
Classification: Class II
Status: Terminated
Initiated: 2017-05-19
Terminated: 2018-05-29
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K130299 — GMK HINGEMedacta International·cleared 2013-08-15

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

Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO

Reason for recall

One lot of product does not include a screw for attachment to the tibial base plate.

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