PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: July 12, 2017 Initiated: May 19, 2017 #Z-2661-2017

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.

Details

Recalling Firm
Medacta Usa Inc
Units Affected
4 units
Distribution
CA, AZ, NC, Israel, France
Location
Memphis, TN

Frequently Asked Questions

What product was recalled?
Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO. Recalled by Medacta Usa Inc. Units affected: 4 units.
Why was this product recalled?
One lot of product does not include a screw for attachment to the tibial base plate.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 12, 2017. Severity: Moderate. Recall number: Z-2661-2017.