K2M, Inc: Medical Device Recall in 2020 - (Recall #: Z-2028-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90169, UDI # 10888857108820, Size 28x10mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy.

Product Classification:

Class II

Date Initiated: April 13, 2020

Date Posted: May 27, 2020

Recall Number: Z-2028-2020

Event ID: 85491

Reason for Recall:

The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.

Status: Terminated

Product Quantity: N/A

Code Information:

Lot # FKXU

Distribution Pattern:

Worldwide distribution - US Nationwide distribution including in the states of Colorado, Michigan, Texas, California, New York, Florida, Maryland, Oregon, Kansas, Montana, Missouri and the country of Europe.

Voluntary or Mandated:

Voluntary: Firm initiated