Aspen Surgical Products, Inc. recalls Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100

Recall date

July 23, 2021

Source

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

Recall number

Z-2389-2021

FDA classification

Class II

Brand / firm

Aspen Surgical Products, Inc.

Sold / distributed

US nationwide distribution. No foreign distribution.

Why it was recalled

Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.

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

What was recalled

Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100