Aesculap Surgical Needle recalled over sterility concerns

Recall date

May 18, 2023

Source

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

Official notice title

Aesculap Implant Systems LLC recalls Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610

Recall number

Z-2146-2023

FDA classification

Class II

Brand / firm

Aesculap Implant Systems LLC

Sold / distributed

US Nationwide distribution in the states of DC, MO, PA, TX.

Why it was recalled

Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.

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

What was recalled

Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610