Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2016 - (Recall #: Z-2638-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement

Product Classification:

Class II

Date Initiated: July 18, 2016

Date Posted: August 31, 2016

Recall Number: Z-2638-2016

Event ID: 74850

Reason for Recall:

The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.

Status: Terminated

Product Quantity: 1 unit

Code Information:

P239175

Distribution Pattern:

AR, MN,MA

Voluntary or Mandated:

Voluntary: Firm initiated