K2M product recalled over sterility concerns

Recall date

April 13, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

K2M, Inc recalls K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90…

Recall number

Z-2015-2020

FDA classification

Class II

Brand / firm

K2M, Inc

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90125, UDI # 10888857108387, Size 24x8mm, 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.